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Coverage of Taltz by Medicare Part B

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1. Introduction

The Taltz signaling cytokine involved in the pathogenesis of psoriatic arthritis and psoriasis. The PSUMMIT trial had 2/3 of patients weigh under 100kg, with the remaining patients having a dose of 120mg Taltz IV at weeks 0-4, then every 2 weeks to week 24, with or without MTX and placebo group. High bone regression and joint damage was seen in patients taking Taltz + MTX. Taltz had similar PsARC and ACR20/50 response rates in patients in the SPIRIT trial, with the treatment group having higher ACR70 response rates.

Taltz was approved by the FDA on December 11, 2017 for the treatment of active psoriatic arthritis. This approval was based off of the PSUMMIT and SPIRIT trials, with patients that included both radiographic and non-radiographic evidence of psoriatic arthritis. A significant portion of these patients had concurrent diagnosis of psoriasis.

Of the 1.1 million Medicare beneficiaries with diagnosed psoriasis, over 125,000 with psoriasis will develop psoriatic arthritis. CMS denied the request in part because “psoriatic arthritis is not a form of psoriasis and does not develop secondary to psoriasis”. The decision memo provides a brief history and statement of the use of Taltz and other biologic DMARDs to treat psoriatic arthritis and psoriasis that CMS reviewed, in response to request for section 15.89.

Taltz has shown to be useful in improving signs and symptoms and physical function in patients with psoriatic arthritis, as well as slowing progression of bone carcinogenesis and joint damage.

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2. Overview of Medicare Part B

Medicare Part B, as it outlines in its own official publication, is “Medical Insurance”. It is more than just a myth, though. This program has been providing medical insurance to seniors and disabled persons since 1966, altering healthcare in the process. Any person enrolled in Medicare Part B who resides in a Taltz approved facility is eligible for coverage of Taltz. There are three conditions for coverage of the drug: it must be reasonable and necessary for the patient, the costs must meet the conditions of coverage, and the drug itself must meet the criteria of coverage in Medicare. Conversely, the annual milestone therapy amount for 2016 for Taltz is £3,600. Coverage of Taltz under Medicare Part B for personal patients is only 80%. Patients must obtain and complete the appropriate form for the Medicare Part B program. Obtaining coverage of Taltz in a hospital outpatient setting may prove a lot simpler. Under the Medicare Part B Taltz for a patient being treated at a hospital outpatient setting is 100%. This grants automatic coverage of the drug to any patient who meets the conditions of coverage, so it is suitable for any patient who meets the criteria of coverage in Medicare. (Wu et al.2021)(Asante et al.2024)(Dyrda et al.2022)(Bhattacharya et al.2020)(Mease et al.2022)(Feldman et al.2021)

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3. Taltz: An Introduction

Secukinumab, injected under the brand name Taltz, is a very new type of medication. It was approved for use by the FDA in March of 2016, and as such, there is an ongoing process of learning about the drug. It is thought to be a very effective medication for psoriatic arthritis and moderate to severe plaque psoriasis, which are both conditions often afflicting the older population. Taltz is a very selective immunosuppressive drug, targeting specifically IL-17A. By blocking this cytokine from causing further inflammation, Taltz is able to interrupt the chain of events that would otherwise lead to chronic, painful symptoms of psoriatic arthritis and psoriasis. The way in which Taltz is administered can be considered advantageous to those on other biologics, as it comes in the form of a self-injected pen. This gives the patient some extra independence and they would not need to visit a doctor’s office, as well as there not being any risk of infection from the injection not done properly. Taltz would be a cheaper alternative to other biologics if given Medicare Part B coverage due to price negotiations. Pricing this year is set at $18,500 for a prefilled auto-injector, syringe, or pen, which is more than 15 percent less than the current costs of Humira (adalimumab), the leading medication for psoriatic arthritis. Step therapy and prior authorizations to use other drugs before being able to use Taltz would make for some difficult access to the drug. However, Medicare Part B and Step 2 or 3 of Medicare Part D would hopefully not have such limitations. It is important to consider all possibilities and outcomes when contemplating the use of a newer drug such as Taltz. Coverage may likely lead to saved costs in the future from prevention of severe symptoms, and it would be safer and more effective than regular systemic treatments for older patients. However, it is unknown whether Medicare Part B coverage could change pricing of the drug or alternative costs related to the patient. Fortunately, the information is being regularly updated about the drug so it can be closely monitored.

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4. Coverage of Taltz under Medicare Part B

Taltz may be available to covered Medicare beneficiaries through Medicare Part B (medical insurance for outpatients). Clarification and advice on this issue is available from the Centers of Medicare and Medicaid Services (CMS). Taltz is an FDA approved drug for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Medicare has provided coverage to enrollees for Part B medications when the drugs are reasonable and necessary for the treatment of an illness or injury and are not usually self-administered. Step therapy requirements have never applied to enrollees with a Part B benefit. It is also important to consider whether the patient has a Medigap or Medicare Advantage plan since the coverage may be different from traditional Medicare. Coverage and rules for Part D (prescription drug benefit) plans can be specific to plan and insurance and would not be covered in this discussion. Taltz is a self-administered drug. Part B or a Part D plan may provide coverage. Taltz is not currently listed with the specific details of C-codes or coverage in which there are other providers for the drug infusion. Infusion coverage is another issue and would not be discussed here. (Dean et al., 2024)(Oulee et al.2022)(Naci et al.2022)(Bhattacharya et al.2020)(Pricing, 2020)(Blauvelt et al.2020)(Bagel et al.2021)

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5. Conclusion

This paper attempts to justify why Cyramza and Tymlos should be placed in a different class within the ASP world of Part B versus the ASP of other Part B drugs and biologics. It is very important to seek to attain equity and fairness in the ASP world between all drugs and biologics that are similar therapeutic and disease-state matches for one another. Regardless of cost of prior treatments, disease severity, or the medical needs of the patient, the ASP of Cyramza and Tymlos should match the ASP of other drugs and biologics that are used to treat similar diseases and in similar therapeutic settings. This is a stipulation of the MMA and if drugs and biologics that are similar to one another do not have similar ASPs, then we are not adhering to the MMA. So, this comparison of Cyramza and Tymlos with drugs and biologics used to treat similar conditions is an important comparison to do. Our analysis of Cyramza and Tymlos as potentially misclassified Part B drugs hopes to aid in CMS’s decision making for the placement of these drugs into the appropriate Part B payment category. Decision making would be facilitated through our offering of an analysis of what it means to be a TN drug, our breakdown of the various components of a payment code and what they mean, and our discussion of the implications of Cyramza and Tymlos coverage on Medicare beneficiaries. While CMS makes decisions regarding Medicare policy, our hope is that the beneficiary is at the forefront of these decisions, with the best interests for Medicare patients in mind. As ASP is a pricing standard for physician or hospital therapies, often the value and effectiveness of a drug or biologic is not assessed when it is determined whether the drug is a Part B drug. Step 1 in our logic model hopes to find whether this was the case with Cyramza and Tymlos. The logic model serves an overall guideline for our paper that continues to ask the question of how the placement of these drugs as Part B drugs would affect Medicare beneficiaries. This analysis of the coverage of Cyramza and Tymlos by Medicare Part B is intended to serve as a precedent for future analyses of similar drugs. With the rise of biologics and biologic-like drugs, it is important to examine the coverage of these drugs versus their predecessor drugs and what this means for off Medicare cost for the beneficiary. ~!fin~! Step 2 in our logic model notes the ASP is a pricing standard for physician or hospital therapies, often the value and effectiveness of a drug or biologic is not assessed when it is determined whether the drug is a Part B drug. Step 3 then asks what are the financial implications, both good and bad for the provider and the beneficiary, and for step 4 we hope to discuss how the coverage of Cyramza and Tymlos can be used as a learning experience for future similar drugs.

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References:

Wu, J.J., Harrison, R.W., Zhu, B., Goldblum, O.M., Malatestinic, W.N., Burge, R. and Murage, M.J., 2021. Understanding characteristics of patients newly initiating ixekizumab: findings from the Corrona Psoriasis Registry. Journal of Comparative Effectiveness Research, 10(2), pp.157-167. becarispublishing.com

Asante, K., Racsa, P., Bloomfield, A., Cornett, D. and Schwab, P., 2024. Comparison of a second TNFi vs other biologic or targeted synthetic DMARD following an initial TNFi. Journal of Managed Care & Specialty Pharmacy, 29(10), pp.1109-1118. jmcp.org

Dyrda, P., Vannabouathong, C., Peter, K., Bansback, N. and Tadrous, M., 2022. Utilization of Old-Versus New-Generation Biologics for Plaque Psoriasis for Public and Private Payers in Canada. Canadian Journal of Health Technologies, 2(6). canjhealthtechnol.ca

Bhattacharya, R., Herren, K., Poonawalla, I., Bunniran, S., Bloomfield, A. and Schwab, P., 2020. Comparing medical utilization and cost outcomes in oral versus injectable immunotherapy users with chronic inflammatory joint and skin diseases. Journal of Managed Care & Specialty Pharmacy, 26(10), pp.1246-1256. jmcp.org

Mease, P.J., Young, P., Gruben, D., Fallon, L., Germino, R. and Kavanaugh, A., 2022. Early real-world experience of tofacitinib for psoriatic arthritis: data from a United States Healthcare Claims Database. Advances in therapy, 39(6), pp.2932-2945. springer.com

Feldman, S.R., Zhang, J., Martinez, D.J., Lopez-Gonzalez, L., Hoit Marchlewicz, E., Shrady, G., Zhao, Y. and Mendelsohn, A.M., 2021. Real-World biologic and apremilast treatment patterns in patients with psoriasis and psoriatic arthritis. Dermatology Online Journal, 27(9). escholarship.org

Dean, O., Tausk, F., & Singh, P., 2024. Adoption of newly FDA-approved targeted immunomodulatory therapies by dermatologists: a cross-sectional analysis of Medicare Part D claims from 2013 to 2018. Archives of Dermatological Research. researchsquare.com

Oulee, A., Javadi, S.S., Ahn, G.S., Maul, J.T. and Wu, J.J., 2022. Medicare Part D Prescription Claims for Brodalumab: Analysis of Annual Trends for 2017-2019. Cutis; cutaneous medicine for the practitioner, 110(4), pp.212-214. uzh.ch

Naci, H., Kyriopoulos, I., Feldman, W.B., Hwang, T.J., Kesselheim, A.S. and Chandra, A., 2022. Coverage of new drugs in Medicare Part D. The Milbank Quarterly, 100(2), pp.562-588. wiley.com

Pricing, P. D., 2020. REPORT TO CONGRESS. hhs.gov

Blauvelt, A., Shi, N., Burge, R., Malatestinic, W.N., Lin, C.Y., Lew, C.R., Zimmerman, N.M., Goldblum, O.M., Zhu, B. and Murage, M.J., 2020. Comparison of real-world treatment patterns among psoriasis patients treated with ixekizumab or adalimumab. Patient preference and adherence, pp.517-527. tandfonline.com

Bagel, J., Glick, B., Wu, J.J., Chopra, I., Song, X., Brouillette, M., Mendelsohn, A., Rozzo, S. and Han, G., 2021. Dose escalation and associated costs in biologic treatment of psoriasis based on real-world data. Journal of Medical Economics, 24(1), pp.782-791. tandfonline.com

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