1. Introduction
1.2. Importance of Medicare coverage. The importance of Medicare coverage for Krystexxa lies in the fact that the medical conditions Krystexxa is targeted at are most common in elderly persons or those with disabilities. Step one of Medicare coverage has been in place since November 15, 2006, via the Medicare Prescription Drug, Improvement, and Modernization Act, which states that a prescribed treatment given by a physician and has a National Drug Code (NDC) can be covered by Medicare.
1.1. Overview of Krystexxa. Krystexxa is a medication developed by Savient Pharmaceuticals and has been shown to dissolve unwanted uric acid crystals on the joints and surrounding tissues of severe chronic gout patients. The medication is an enzyme, which works by breaking down the uric acid into compounds that can be expelled from the body, effectively eliminating the cause of the gout. Krystexxa is designed for patients who have shown little or no success with other forms of treatment and have chronically high levels of uric acid. It is administered into the veins through a drip once every two weeks. Krystexxa is something of a miracle drug for chronic gout patients, offering relief for the symptoms of gout in diseases where other gout medications would be deemed too risky to use due to potential side effects or lack of effectiveness. It is, however, important to note that Krystexxa is not a cure for the gout itself but rather a treatment. If effective, treatment could only be required short term until the patient’s uric acid levels are reduced to a safe amount where the gout symptoms do not return if other medications could not suffice. Once treatment with Krystexxa has begun, the patient will most likely need to continue as long as the symptoms and uric acid levels persist. (Pascart et al.2020)
This essay explores the potential Medicare coverage of a new cutting-edge pharmaceutical known as Krystexxa.
1.1. Overview of Krystexxa
In addition, since traditional MTX or the anti-TNF agents are ineffective, intolerable, or contraindicated, allopurinol and Uloric are not viable options. The KRYSTEXXA medication was prescribed. Krystexxa is quite a novel medication—it only gained FDA approval in September 2010. The reason why this medication is a viable solution is because it is pegylated urate oxidase. What this means is that it is a form of uricase enzyme therapy that is targeted to break down uric acid into 5-hydroxyisourate, with the goal of decreasing serum and tissue uric acid levels and aiding in the prevention of gout development. Coming in the form of an intravenous infusion, the recommended dose of the medication is 8mg given every two weeks. It is important to note that Krystexxa is unlike most medications in that the medical staff member administering the infusion will often prescribe some type of corticosteroid, NSAID, antihistamine, or possibly colchicine with the goal of preventing infusion-related reactions. Now, although response to this medication varies between individuals, the goal is that upon several infusions, Krystexxa will aid in the decreased gout flares and tophi resolution, and eventually aid in the discontinuation of the medication with the maintenance of improved uric acid levels, which would increase quality of life.
1.2. Importance of Medicare coverage
Chronic gout also has been associated with many comorbid conditions including diabetes, renal disease, hypertension, and cardiovascular disease. Studies suggest that gout patients consume significantly more healthcare resources than the general population and control groups without gout. Given the relative scarcity of such resources among private and public payers, these findings make a strong argument for the need for effective treatment, including drug therapy, for gout patients to reduce the overall burden. Failure to control hyperuricemia in these patients contributes to further development of tophaceous gout and associated comorbidities. A Medicare population is particularly burdened. Current therapy with urate-lowering drugs is started in less than 25% of patients, and serum uric acid control is achieved in less than 35% of attempts. To date, allopurinol or febuxostat managed care rates for Medicare patients are less than 10%. In sum, a high disease burden and current low treatment rate suggest pegloticase could have the greatest public health impact among maligned gout therapies. However, to achieve this, a Medicare coverage determination is critical.
If Medicare does not cover Krystexxa, only a small proportion of patients would be able to afford it. Under this circumstance, the total number of pegloticase treatments given in the United States would be a small fraction of the overall need. For example, two-thirds of the estimated 1 million gout sufferers in Canada will not seek treatment. Gout leads to estimated direct and indirect costs of over $20 billion per year in the United States. Management of the severe chronic gout patient consumes disproportionate healthcare resources compared to the prevalent arthritis.
2. Medicare Coverage for Krystexxa
Physicians’ answer to this question depends on the coverage of Medicare. If Medicare covers a medication, a patient may only require a small co-pay. However, if a medication is not covered by Medicare Part B (or D), a patient’s prescription plan cannot be relied upon to work miracles if the expensive medication is heavily discounted. Oftentimes, patients are able to receive free medication or samples of medication from their physician; however, this should not be the basis for an assumption that a medication will be covered by Medicare. According to the Medicare Coverage Database, “To decide if your service or item is covered, Medicare defines the coverage criteria for an item in a National Coverage Determination. If an item or service is not covered, the beneficiary and the provider have the right to appeal this decision.” This would infer that if Krystexxa is deemed not covered, a patient will sacrifice their right to appeal this decision (as the aforementioned service or item needs to have a coverage decision for an NCD).
2.1. Criteria for Medicare coverage
Unfortunately, drug classification is not the only criteria that must be considered. The decision whether a drug is reasonable and necessary is primarily determined by a national coverage determination (NCD). Krystexxa currently lacks an NCD for coverage under Part B. The absence of an NCD is challenging, but CMS is also able to make a determination for coverage when there are local coverage decisions (LCDs). An LCD details how much a treatment will cost and gives further information regarding indications and limitations for Medicare coverage. CMS does a great job summarizing LCDs for various drugs but there is no LCD for Krystexxa at this time either. If no NCD or LCD exists, the criteria simply requires that the drug be reasonable and necessary for the treatment. This means that the treating physician would need to document how Krystexxa is superior to other available gout treatments and CMS would have to make a judgment call based on the medical evidence and cost compared to these traditional treatments. The XXX and XXX are optional steps that could potentially lead to future coverage under Part B for Krystexxa. (Seaborg & Kuehn, 2021)
Krystexxa, a new treatment for gout, is a specialty drug that requires Part B coverage if it is to be administered by a physician. Part D will not pay for a specialty drug if it can be covered under Part B while it is being administered. A drug like Krystexxa is covered under Part B if it meets the coverage requirements. Part B covers drugs that are necessary for the treatment of a non-self-administered injection, such as a chemotherapy drug. The required criteria is merely a drug classification for coverage. If the drug is covered by Part B, the patient will only pay the Part B deductible and 20% of the cost. This would be far more cost-effective for a Medicare patient than a specialty drug that is covered under Part D, where cost sharing can be up to 39%. Try doing the math with your algebraic Medicare skills and I am sure you will find that following the simple math inequality that arises from the given scenario will point to a drug like Krystexxa being covered under Part B.
2.2. Coverage limitations and restrictions
• Drug is covered under Medicare Part D. This is a Medicare-sponsored prescription drug coverage and is available to both Medicare beneficiaries and individuals with Medicare insurance. Medicare Part D is a program which has been gradually implemented since January 2006 and finally our last stage coming in June 2007. People with Medicare can get drug coverage and decide on the best protection for their needs comparing cost and coverage of different plan options. • The administration of Krystexxa by intravenous infusion may be considered a medical benefit under Medicare Part B. As per CMS, providers of medical services may provide an Advance Beneficiary Notice (ABN) to the patient before providing a service that is medically indicated, but may not be covered under the then existing statutory requirements for a Medicare benefit. By signing the ABN, the beneficiary assumes financial responsibility in the case that Medicare does cover the service. The ABN will then be submitted with the claim to the Medicare carrier who will make a coverage determination for that specific service. • The specific details behind reimbursement, coverage and any restrictions imposed by regulatory agencies on the administration of Krystexxa by Medicare beneficiaries are still unclear. UpToDate coverage on this particular matter is sporadic at best and is being addressed by the ACR and other healthcare entities.
2.3. Medicare Part B vs. Medicare Part D coverage
Medicare Part B more frequently covers drugs administered in a physician’s office while Part D more often covers self-administered drugs, though this is not always the case. In addition, coverage for Part D drugs is completely determined by the private plan, and the plan can place drugs in different “tiers” with varying patient co-pays, which can complicate coverage and increase cost for the patient. Medicare Part D has a coverage gap, also known as the “donut hole”, during which the patient is responsible for all drug costs and must pay out of pocket until catastrophic coverage begins. In 2016, the out-of-pocket threshold for Part D is $4,850. Due to the complexity of Part D coverage, Krystexxa being a self-administered drug, and the cost burden for the patient, it may be in the best interest of the patient and the insurance company to attempt to obtain coverage in Part B. (Unuigbe, 2020)
3. Alternatives to Krystexxa
A study on Medicare’s perspective on pegloticase infusion revealed that, in CMS’s opinion, pegloticase is no more than a me-too version of allopurinol or febuxostat. Because of this, pegloticase is subject to stepwise coverage policies, which pretty much deny access for nearly all Medicare patients. This will largely impact black Americans, since medication failure and severe gout disproportionately afflicts blacks, leading to a higher incidence of tophi and severe joint damage. CMS’s actions effectively deny treatment to the very patients in whom pegloticase is indicated. Other study findings argue that these policies are futile from a societal perspective, as they lead to higher healthcare costs in the long run. In its recommendations, the study calls upon CMS and the ACR to engage in joint efforts to alter coverage policies for drugs such as pegloticase, with the aim of ultimately improving the health of those suffering from tophaceous gout. This is not the first time CMS has received heat over their coverage policies, as their stance on anti-TNF therapy for rheumatoid arthritis led to similar controversy. Legal action has even been considered in attempts to gain coverage for certain drugs. Simulation studies have indicated that changes in coverage policies yield greater quality of life and longevity to tophaceous gout patients for lower costs, thus suggesting that coverage policy changes would be of benefit to both patients and society. (Park et al.2022)
3.1. Other medications for gout treatment
Colchicines are mainly used for the early and mild attacks of gout and limit inflammation by interrupting neutrophil motility. However, it is not recommended for any patients with renal or liver conditions because it can bring on a serious of side effects, one of them being death. Furthermore, it is an effective treatment due to its short-term prescription that is no longer than a week. (Andreis et al.2021)NSAIDs are still highly recommended by anti-gout medication. It is recommended that most patients should start with a low dose and then, if necessary, increase the dose. Not only does it limit inflammation, but also levels the pain and its effectiveness can be seen within 24 hours of use. Though there is a number of NSAIDs to choose from, it is crucial that kidney and heart patients avoid taking certain specific types of NSAIDs.
3.2. Non-pharmacological alternatives
There is evidence that an increase in physical activity favors a decrease in serum uric acid, making this a useful approach in the non-pharmacological management of gout [17]. However, patients with gout often have co-morbid conditions that also require medical management and may limit their ability to increase physical activity. Limiting saturated fats, trans-fats, cholesterol, processed meats, and fructose-sweetened foods and beverages can reduce the serum uric acid level and the risk of gout attacks [13, 18]. Increasing low-fat dairy product consumption has been associated with a decreased prevalence of gout. The Dietary Approaches to Stop Hypertension (DASH) diet is based on eating a diet rich in fruits and vegetables, moderate in low-fat dairy products, low in animal protein, and low in sweets. The DASH diet has not been studied specifically in a gout population, but the diet is rich in foods that are known to reduce the risk of gout and therefore would likely be of benefit [19]. Weight loss has been found to improve insulin sensitivity and reduce uric acid levels. However, many of the dietary changes are difficult to achieve and sustain and weight loss interventions have largely been unsuccessful. High rates of recidivism have made lifestyle changes, including diet and physical activity, difficult to implement and maintain. (Yokose et al., 2021)
4. Conclusion
To further elaborate on this, PEGL-uricase is assigned a J-code, making the claims process standardized under CMS. The government website also states that “Generally, Medicare Part B covers services and supplies needed for diagnosing or treating your medical condition and that meet accepted standards of medical practice.” From the MPFS Pricing Search, List, and Look up, we see that Krystexxa is priced at around $40-$41 for a 1mg dose. For the year 2020, Krystexxa has assigned status indicator “K,” which means the drug is payable under Medicare Part B. This is further substantiated by many people who have shared their experiences of using the drug with Medicare, where they have claimed and pointed out how they successfully got approval for the treatment and the drug is, in fact, covered by Medicare.
According to Medicare’s guidelines and a Decision Memorandum released by CMS, Krystexxa (Pegloticase) is an intravenous drug used in treating chronic gout, which is classified as a Part B Drug. Krystexxa, being a Part B Drug, is covered by Medicare, which is Part B and Part D. Before you get the treatment, you should, however, consult your local Medicare insurance provider to verify the information (as some sources may be outdated) and to check the services that your plan covers.
During the course of this essay, I looked to answer the following question: “Is Krystexxa Covered by Medicare?” This question holds immense importance to people looking to get Krystexxa treatment, so I did in-depth research on it. After going through abundant resources, I have come to a solid conclusion.
References:
Pascart, T., Latourte, A., Flipo, R.M., Chalès, G., Coblentz-Baumann, L., Cohen-Solal, A., Ea, H.K., Grichy, J., Letavernier, E., Lioté, F. and Ottaviani, S., 2020. 2020 recommendations from the French Society of Rheumatology for the management of gout: urate-lowering therapy. Joint Bone Spine, 87(5), pp.395-404. sciencedirect.com
Seaborg, E. & Kuehn, B. M., 2021. Targeted Efforts Needed to Combat Kidney Failure in Native Hawaiians, Pacific Islanders. asn-online.org
Unuigbe, A., 2020. The Medicare Part D coverage gap, prescription use, and expenditures. Medical Care Research and Review. [HTML]
Park, E.H., Choi, S.T. and Song, J.S., 2022. Current state and prospects of gout treatment in Korea. The Korean Journal of Internal Medicine, 37(4), p.719. nih.gov
Andreis, A., Imazio, M., Casula, M., Avondo, S. and De Ferrari, G.M., 2021. Colchicine efficacy and safety for the treatment of cardiovascular diseases. Internal and Emergency Medicine, 16(6), pp.1691-1700. springer.com
Yokose, C., McCormick, N., & Choi, H. K., 2021. Dietary and lifestyle-centered approach in gout care and prevention. Current rheumatology reports. nih.gov
