Radar on Specialty Pharmacy

Targeted therapies have made tremendous progress in oncology, with some products essentially rendering some cancers chronic conditions. According to the National Cancer Institute, the FDA has approved hundreds of targeted therapies across 30 types of cancers. Genomic testing can help determine whether a patient is a candidate for a particular therapy, and CVS Health has launched a program focused on boosting patient access to this.

In 2018, CMS finalized a national coverage determination (NCD) for diagnostic laboratory tests that use next-generation sequencing (NGS) for patients with advanced cancer in order to gain a comprehensive genomic profile (RSP 4/18, p. 12). The NCD said that CMS will cover NGS in vitro diagnostic (IVD) tests for Medicare beneficiaries with advanced cancer who have not been tested with the same NGS technology. It also said CMS will cover FDA-approved or cleared companion IVDs “when the test has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options.”

BlueCross BlueShield of Tennessee, Inc. (BCBST) has found itself in the news recently but probably not for reasons the health plan might like: The insurer has received tremendous pushback from physicians on its decision to implement a policy requiring them to get provider-administered therapies from specialty pharmacies. But the health plan maintains that it has implemented the program in response to client demands and that the new policy will save money for its self-funded employers that opt into the program.

Providers traditionally have acquired therapies they administer through a practice known as buy and bill, by which they will purchase a drug from a wholesaler or distributor, keep it in their office and administer it to patients as needed, submitting a claim to the payer afterwards. Through this approach, providers can make a profit by marking up the drug.

✦ Pfizer Inc. unveiled its launch strategy for three biosimilars. Zirabev (bevacizumab-bvzr) launched Dec. 31 at a wholesale acquisition cost (WAC) of $61.343 per 10 mg, a 23% discount to that of reference drug Avastin (bevacizumab), from Genentech USA, Inc., a member of the Roche Group. Ruxience (rituximab-pvvr) launched Jan. 23 at a WAC of $71.68 per 10 mg, a 24% discount to the WAC of reference drug Rituxan (rituximab) from Genentech and Biogen. And Trazimera (trastuzumab-qyyp) will launch Feb. 15 with a WAC of $80.74 per 10 mg, a 22% discount to that of Genentech’s Herceptin (trastuzumab). View the press release at https://bit.ly/2RV1vll.

✦ Infused oncology drug payments are almost two times more in hospital outpatient departments (HOPDs) than they are in physician offices (POs), according to an issue brief from the Employee Benefit Research Institute (EBRI) Center for Research on Health Benefits Innovation. The analysis looked at 18,195 users of the top 37 infused cancer therapies for employment-based and commercially insured patients in 2016. Researchers found that those drugs cost 86.2% more on average per unit in the HOPD setting vs. PO, with HOPDs being reimbursed an average of $8,753 more per patient. The reimbursement difference, researchers found, was “primarily due to differences in prices rather than differences in treatment modality.” For more information, download the issue brief at https://bit.ly/2umwmyf.

✦ Jan. 8: The FDA expanded the label of Keytruda (pembrolizumab) to include the treatment of people with bacillus Calmette-Guérin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have decided not to undergo cystectomy. The agency initially approved the programmed death receptor-1 (PD-1) inhibitor from Merck & Co., Inc. in 2014 (RSP 9/14, p. 4), and it is approved for more than 20 cancer indications. The recommended dose for the newest indication is 200 mg infused intravenously over 30 minutes every three weeks. GoodRx lists the price of one 100 mg/4 mL vial as more than $9,600. For more information, visit www.keytruda.com.

✦ Jan. 9: The FDA approved Blueprint Medicines Corp.’s Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha exon 18 mutation, including PDGFRA D842V mutation, the most common exon 18 mutation. The agency gave the kinase inhibitor breakthrough therapy, fast track and orphan drug designations. Tablets are available in 100 mg, 200 mg and 300 mg strengths, and dosing is 300 mg once daily. The company priced all three strengths at $32,000 per 30 days. Visit https://ayvakit.com.

Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs.

But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders, including providers, patients and manufacturers.