Opzelura (generic name ruxolitinib cream 1.5%) is a prescription topical medication. It is the first topical Janus kinase (JAK) inhibitor approved for certain skin conditions. JAK inhibitors modulate the immune response by blocking JAK1/JAK2 enzymes, which in turn reduces inflammatory signals. Opzelura comes as a cream applied to the skin.
What it’s used for: Opzelura is approved to treat:
- Nonsegmental vitiligo – an autoimmune condition causing patchy loss of skin pigment. Opzelura is the first approved treatment to repigment vitiligo in the US and EU. It helps restore skin color over time by stopping the immune system from attacking pigment-producing cells.
- Mild to moderate atopic dermatitis (eczema) – a chronic inflammatory skin disease causing itchy, red rashes. Opzelura is used short-term or intermittently for patients 12 and older who haven’t responded to first-line therapies like corticosteroid creams. It can reduce inflammation and itch in eczema by targeting immune pathways in the skin.
How it works: By inhibiting JAK enzymes, Opzelura calms overactive immune signals in the skin. In eczema, this leads to less inflammation and itch. In vitiligo, it’s thought to prevent the immune system from destroying melanocytes (pigment cells), allowing some repigmentation of white patches
. Patients apply a thin layer of the cream to affected areas (usually twice daily). Treatment often needs to continue for several months before significant repigmentation is seen in vitiligo. Opzelura should only be used on up to 10% of body surface area at a time, and under a doctor’s supervision, especially since it’s a newer immune-modulating drug.
Availability and Prescription Requirements by Country
United States
Approval and prescription process: In the U.S., Opzelura is fully approved by the FDA for both nonsegmental vitiligo and atopic dermatitis. The FDA first approved Opzelura in September 2021 for eczema and in July 2022 for vitiligo. This means U.S. patients can only obtain Opzelura with a valid prescription. Typically, a dermatologist or other healthcare provider will evaluate if you are a candidate. For eczema, doctors usually prescribe Opzelura if conventional treatments (like steroid creams or calcineurin inhibitors) haven’t worked or aren’t advisable. For vitiligo, dermatologists may prescribe it for actively depigmented areas, often focusing on visible areas such as the face. There is no special license needed by the doctor beyond the normal prescription, but because Opzelura is a novel therapy, many physicians prescribing it will be specialists in dermatology.
Insurance coverage: Most U.S. insurance plans will consider covering Opzelura since it’s FDA-approved, but because of its high cost, prior authorization is commonly required. This means your doctor may need to submit documentation to your insurer showing that: (1) you have the diagnosed condition (vitiligo or atopic dermatitis), and (2) you have tried standard treatments first or have a medical reason why you can’t use them. For atopic dermatitis, insurers often require that you’ve attempted other topical therapies before approving Opzelura. For vitiligo, Opzelura is the first-of-its-kind treatment, so insurers focus on confirming the diagnosis and extent of vitiligo. Once approved, insurance will pay the bulk of the cost, but your co-pay or co-insurance will depend on your plan.
Out-of-pocket costs: Without insurance, Opzelura is very expensive. The list price (Wholesale Acquisition Cost) in the U.S. is about $2,094 USD for one tube (60 grams). Pharmacies report a cash price in the range of $2,000–$2,200 per 60g tube. This high cost means most patients rely on insurance or assistance.
Patient assistance programs: The manufacturer (Incyte) offers Opzelura On-Track™ support, including a copay savings card and a patient assistance program. For privately insured patients, the Opzelura copay card can reduce your cost to as little as $0 per tube (with certain annual maximums). This is meant for those with commercial insurance – it cannot be used if you are on government insurance like Medicare or Medicaid. Patients on Medicare who need Opzelura may face a high coinsurance due to the drug’s cost (unless they reach catastrophic coverage). For uninsured or underinsured individuals, Incyte’s Patient Assistance Program may provide Opzelura free of charge if you meet income and eligibility criteria. These programs typically require your doctor to submit an application on your behalf. Additionally, some dermatology clinics help patients obtain “bridge” supplies of the medication while waiting for insurance approval. It’s also worth checking if foundations related to vitiligo or eczema offer any financial assistance or samples.
Official resources (U.S.): The FDA’s announcement of Opzelura’s approval provides details on its indications. For insurance and cost questions, the official patient support site (Opzelura On-Track) provides information on copay cards and free drug programs. (See the Helpful Links section at the end for direct links.)
Canada
Approval status: In Canada, Opzelura was recently approved by Health Canada. In October 2024, Health Canada granted Notice of Compliance (formal approval) for Opzelura for two uses: (1) mild to moderate atopic dermatitis in patients 12+ who haven’t responded to typical treatments, and (2) nonsegmental vitiligo in patients 12+. This made Opzelura the first and only approved medication for vitiligo repigmentation in Canada. After approval, the drug can be marketed in Canada. The manufacturer (Incyte Biosciences Canada) will supply it to pharmacies, but availability might ramp up gradually as distribution channels are established.
How to get a prescription: Like any prescription drug, you’ll need to see a healthcare provider. Likely, a dermatologist will be the one to initiate Opzelura for vitiligo or eczema. They will assess if you meet the criteria (for example, vitiligo affecting a certain body surface area, or eczema that hasn’t improved with steroids). There is no special federal program required now that it’s approved – your doctor can write a prescription that you take to a pharmacy. Do note, because it’s new, not all pharmacies may have it in stock yet. They might order it upon receiving a prescription. It could be helpful to call ahead to larger or specialty pharmacies. Your dermatologist might also have information on availability or samples.
Public insurance (provincial coverage): Canada’s healthcare system covers medications through provincial drug plans (for example, the Ontario Drug Benefit, BC PharmaCare, etc.), each with its own formulary. As of early 2025, Opzelura is so new that most provincial public plans have not yet listed it for routine coverage. Typically, after Health Canada approval, a drug undergoes a health technology assessment for cost-effectiveness (through bodies like CADTH’s Canadian Drug Agency or provincial review committees). For instance, BC PharmaCare began a review of ruxolitinib cream for atopic dermatitis in late 2024, seeking input on whether it should be covered and under what criteria. Until these reviews are complete and a positive listing decision is made, Opzelura is not automatically reimbursed by provincial health plans. That means if you only have public coverage, you may need to pay out of pocket for now or apply for any special access programs that province might have. In some cases, provincial plans have exceptional access or special authorization mechanisms: your dermatologist can submit a request citing medical need. Since vitiligo has never had an approved drug before, there is hope that provinces may create criteria to cover Opzelura for patients with significant vitiligo, but this will likely happen after formal reviews. Keep an eye on your province’s drug formulary updates.
Private insurance: If you have private or employer-sponsored drug insurance in Canada, there’s a good chance your plan may cover Opzelura, especially for atopic dermatitis, since that’s a more common indication. However, private insurers also often require prior authorization. You and your doctor will need to submit paperwork showing your diagnosis and past treatment history. Some insurers might initially decline coverage for vitiligo since it’s a new indication, but the fact that Health Canada approved it should support your case. Each insurance company (Sun Life, Green Shield, etc.) will have its own criteria. You should contact your insurer or have your pharmacist do a trial claim to see if it’s covered. If it’s not on the formulary yet, your HR benefits or insurance rep might need to consult the insurer’s medical reviewer. This process can take a few weeks.
Cost in Canada: The retail price in Canada has not been widely published as of this writing, but it is expected to be high (likely in the same ballpark as the U.S. price, possibly over CAD $2000 per tube). For example, a similar immunotherapy cream could cost thousands per package, so one can expect Opzelura to be a costly specialty drug in Canada as well. If you have to pay out-of-pocket, pharmacies might ask you to cover the cost upfront. If you cannot afford it, discuss options with your dermatologist. The manufacturer may offer a patient support program in Canada that can assist with insurance navigation and possibly provide interim coverage (pharmaceutical companies often have “compassionate supply” or bridging programs when public coverage is pending). Check if Incyte Canada has a program – your doctor’s office may have the contact information for the local Opzelura representative or support program.
Official guidance and resources (Canada): The Health Canada Drug Product Database would list Opzelura’s approval details, and CADTH (Canada’s Drug Agency) publishes assessment reports and eventually recommendations for reimbursement. For instance, CADTH has been reviewing Opzelura for atopic dermatitis, which signals that provincial coverage decisions are upcoming. Until public coverage is in place, patients can refer to provincial health ministry websites for any special access programs.
Australia
TGA approval status: As of now (early 2025), Opzelura is not yet approved by Australia’s Therapeutic Goods Administration (TGA) for general marketing. In other words, Opzelura is not on the Australian Register of Therapeutic Goods (ARTG) yet. The manufacturer has to submit it for evaluation, and there’s indication that as of 2023 they had not done so. This means you cannot get Opzelura by a standard prescription at a local pharmacy in Australia at this time. The cream is simply not formally available in the country through regular channels.
Special access routes: Even though it’s not TGA-approved, Australian patients with vitiligo or refractory eczema do have some options to obtain Opzelura:
Special Access Scheme (SAS): The TGA allows doctors to prescribe unapproved medicines on a case-by-case basis via the Special Access Scheme
. Your dermatologist can apply to the TGA Category B SAS for you, providing details about your condition and why Opzelura is needed. If approved, this permits the importation and supply of Opzelura for you as an individual patient. Essentially, the doctor would source the medication (often through a partner pharmacy that can import it from overseas). This process can take some paperwork and time. Under SAS Category B, TGA approval is required before you can receive the drug, since vitiligo or mild eczema likely wouldn’t qualify as “life-threatening” for the quicker Category A route (which is reserved for very serious or terminal conditions). The SAS is a well-established pathway: for example, it’s often used for new cancer drugs or drugs awaiting approval. If you go this route, discuss the timeline and import logistics with your doctor.
- Authorized Prescriber Scheme: Alternatively, a dermatologist could become an Authorized Prescriber of ruxolitinib cream. This means the doctor gets permission from the TGA to prescribe Opzelura to multiple patients without needing individual TGA approvals each time. To do this, a doctor must apply, often with an ethics committee approval, showing there’s sufficient evidence of safety and efficacy. If a dermatologist sees many vitiligo patients, they might pursue this so they can treat more people. From a patient perspective, you would still just get a prescription from that doctor, but it’s valid under the authorized prescriber status.
- Compounding: In the absence of the branded product, some compounding pharmacies in Australia have been able to create a compounded ruxolitinib cream (using the active ingredient from other sources, such as the oral form of ruxolitinib). There are anecdotal reports of this, but it’s important to note two things: (1) Compounded medicines are not evaluated by the TGA for safety/quality, so you are relying on the pharmacy’s quality, and (2) cost can be very high because ruxolitinib as a raw ingredient is expensive and not produced at scale for compounding. One Australian patient noted a compounded supply could cost thousands of dollars as well, making it not a very affordable alternative. Still, if you have no other access and are eager to try ruxolitinib, a compounding pharmacist (with a doctor’s prescription) might be an option to discuss. Pharmacies like “Pharmacy Smart” in Victoria have been mentioned in patient forums for compounding ruxolitinib 1.5% cream.
Insurance coverage: Since Opzelura is not registered in Australia, it is not covered by the Pharmaceutical Benefits Scheme (PBS). PBS only subsidizes medicines that the TGA has approved and that have been evaluated by the Pharmaceutical Benefits Advisory Committee for cost-effectiveness. Opzelura would need to go through that process after approval. So currently, any supply of Opzelura (through SAS import or compounding) is private and out-of-pocket. Public hospitals generally won’t have it available either, except perhaps on a trial or compassionate basis. Private health insurance in Australia usually does not cover outpatient prescription drugs (those are normally PBS’s domain). Some high-tier private plans reimburse a portion of non-PBS medications or compounding costs, but this varies and often has low annual limits. It’s worth asking your insurer, but be prepared that you’ll likely bear most or all of the cost.
Given the likely expense, patients may want to limit the treated area (for vitiligo) to make a small amount of cream last longer, or ensure that expectations are clear. Always work with a dermatologist – they might be able to enroll you in any clinical trials or early access programs if available. It’s also possible that in time the manufacturer will submit Opzelura to the TGA, so keep an eye on Australian dermatology news.
Official guidance (Australia): The TGA provides information on the Special Access Scheme for unapproved products and how doctors can help patients access them. Australian patients can refer to this and discuss it with their healthcare provider. We have included the TGA’s SAS info in the links section.
European Union (and UK)
EMA approval: The European Medicines Agency (EMA) approved Opzelura in the EU in April 2023 for the treatment of nonsegmental vitiligo in adults and adolescents 12 and older. (Atopic dermatitis indication was not initially part of the EMA approval; as of 2023, the EU authorization was specifically for vitiligo with facial involvement.) The EMA’s approval means Opzelura has a centralized authorization valid in all EU member countries. It is classified as a prescription-only medicine in Europe. The EMA notes that treatment should be started by a physician experienced in vitiligo management (generally a dermatologist). After the approval, it’s up to each country to decide on pricing and reimbursement through their national healthcare systems.
General prescription process: In any EU country, you will need to see a doctor for a prescription. Dermatologists are the specialists who would handle vitiligo or eczema. Once you have a prescription, you can take it to a pharmacy. In 2023–2024, availability has been rolling out: some countries got the product in pharmacies sooner than others due to local distribution and insurance negotiations. The good news is that if it’s not yet stocked locally, a pharmacy can usually order it for you from the manufacturer’s European supply chain, since the drug is authorized Europe-wide. For example, Germany was one of the first countries where Opzelura became available to patients, soon after the EU approval. By early 2024, it was expected to be accessible in major EU markets like Germany and France
Coverage and reimbursement in Europe: Europe has public healthcare systems, so the cost to patients depends on whether Opzelura is included in the national health insurance formulary of each country:
Germany: In Germany, once a drug is EMA-approved, it can be prescribed and is typically covered by the statutory health insurance (Gesetzliche Krankenversicherung) from day one, pending pricing negotiations. Opzelura has been available in Germany under its brand name since 2023, and insurers (sickness funds) do reimburse it when prescribed for the approved indication. The drug undergoes an “early benefit assessment” by the German authorities, but during that period, patients with vitiligo can get it and the cost is borne by insurance just like any other approved medicine. German insurance usually just requires a standard co-payment (e.g. €5–10) like any prescription, and some plans might require that it’s prescribed by a specialist.
Notably, vitiligo in Germany is not considered merely cosmetic; it’s recognized as a medical condition, which means treatments for it are eligible for coverage (this was clarified so that Opzelura could be covered and not deemed a “lifestyle” drug). Additionally, certain German insurers (e.g. AOK) may have rebate contracts with the manufacturer, but that doesn’t affect the patient’s experience except potentially reducing costs for the system. In summary, German patients can get Opzelura from pharmacies with a doctor’s prescription, and statutory insurance will pay for it minus the small patient co-pay.
France: France has a centralized process to decide reimbursement and pricing after EMA approval. Opzelura went through evaluation by the Haute Autorité de Santé (HAS) in 2023, and by July 2024 France approved Opzelura for reimbursement. The French government set the price at €838.39 for a 100-gram tube, and it officially listed Opzelura as reimbursable by Sécurité Sociale as of July 27, 2024. In France, vitiligo treatment with Opzelura is covered at 65% by the national health insurance, which is the typical rate for most medications.
Patients are responsible for the remaining 35%, but most people have supplementary private insurance (“mutuelle”) that usually covers that remainder. This means many French patients will pay little to nothing out-of-pocket for Opzelura. Initially, before it was added to the public list, France had an early access program through hospital pharmacies (in early 2024) for vitiligo patients. But now that it’s reimbursed and in regular pharmacies, a patient simply gets a prescription and can obtain the cream from any pharmacy (it might be ordered next-day if not in stock). The French vitiligo patient association celebrated this fast access as it significantly improves convenience.
United Kingdom: The UK is no longer in the EU, but it’s often discussed alongside Europe for drug approvals. The UK’s MHRA granted Opzelura a marketing authorization in July 2023 (closely following the EMA decision). So legally, it can be prescribed in the UK. However, for it to be routinely provided by the National Health Service (NHS), NICE (National Institute for Health and Care Excellence) had to evaluate it. NICE’s initial guidance (draft in Jan 2024) was not to recommend Opzelura for routine NHS use for vitiligo, citing cost-effectiveness concerns (they questioned whether the benefit justified the price for widespread NHS funding).
In July 2024, NICE confirmed it would not add ruxolitinib cream to NHS England’s formulary for vitiligo at that time. This means if you have vitiligo in the UK, the NHS will not pay for Opzelura, and GPs or NHS dermatologists generally won’t prescribe it because the health service won’t cover it. However, it is available privately. UK dermatologists can write a private (non-NHS) prescription for Opzelura, which you would pay for out-of-pocket. Some private dermatology clinics in the UK have begun offering Opzelura to vitiligo patients. For example, specialized pharmacies (such as Bramley Pharmacy in Leeds) advertise that they can obtain Opzelura on private prescription.
The cost for a private supply in the UK is significant – early reports suggest on the order of £500–£600 per 60g tube, but exact prices can vary. As of mid-2024, patients were advised to wait for NICE’s final decision, but after appeal, NICE was still reconsidering in 2025 with no guarantee of reversal. For atopic dermatitis, the process in the UK might follow later; the vitiligo decision took priority as it was a new therapy area. If you are in the UK and considering Opzelura, you’d likely be seeing a private dermatologist and should discuss the financial aspect. Note: Scotland and Wales have their own appraisal bodies (SMC and AWMSG), which may come to separate decisions; it’s worth checking those if you’re outside England. But until any NHS coverage is approved, UK patients must self-fund Opzelura.
Other EU countries: Each country has its timeline. Italy, Spain, and others typically negotiate price after EMA approval. By late 2023, some countries might still be in negotiations. For instance, Italy’s Medicines Agency (AIFA) might still be reviewing, so interim access could be via private prescription only. Spain’s system might allow use while awaiting pricing, but patients could need to go through pharmacy committees. Smaller EU countries often wait for a price agreement or might use compassionate use programs.
If you are in an EU country not mentioned above, the best course is to ask your dermatologist or national vitiligo network on the current status. In many EU states, if a drug is not yet reimbursed, a hospital dermatologist could potentially request it on a named-patient basis, or you might obtain it at full price. The EMA authorization guarantees the drug is legal to use; coverage is the remaining hurdle.
Summary of EU insurance: In countries like Germany and France (and likely others soon), public insurance covers Opzelura, meaning patients pay only the standard prescription charge (e.g. France’s small co-pay or Germany’s €10). In countries where it’s not yet covered (UK, and any EU country still pending reimbursement decision), patients must pay the full price to access it. Fortunately, the prices negotiated in Europe seem to be lower than U.S. prices – for example, ~€838 for 100g in France. In Germany, the price might be similar per gram (Germany often initially accepts the list price and then may adjust after a year).
For vitiligo patients in Europe, having Opzelura covered is a significant development since previously only off-label or light therapy options existed. Make sure to connect with patient advocacy groups or online forums in your country – they often share up-to-date practical advice on how to obtain treatments like Opzelura through the healthcare system.
Helpful Links and Resources
For further accurate information on Opzelura’s availability and coverage, consult these official and authoritative resources:
FDA Press Release – Opzelura Approval (USA): FDA News Release on Opzelura’s approval for vitiligo and eczema, including usage and indication details
Opzelura On-Track Patient Support (USA): The manufacturer’s patient support program site, which provides details on the Copay Savings Card and Patient Assistance Program for U.S. patients
Health Canada Notice of Compliance (Canada): Incyte Canada’s announcement of Health Canada approval – confirms the indications approved and Canadian availability timeline
BC PharmaCare Drug Info (Canada): The British Columbia government’s PharmaCare info sheet showing that Opzelura (ruxolitinib cream) is under review for coverage
TGA Special Access Scheme (Australia): TGA’s official page on accessing unapproved products for individual patients
EMA Opzelura Summary (EU): The European Medicines Agency’s Opzelura product page, which provides an overview of the authorized indication (vitiligo), prescribing info, and authorization details
NICE Guidance Index (UK): The NICE record for the appraisal of ruxolitinib cream for vitiligo, showing the status of the evaluation
France – Journal Officiel Notice (FR): Announcement of Opzelura’s inclusion in reimbursed medicines in France, with reimbursement rate and price