MMIT Reality Check on Metastatic Prostate Cancer (1Q2023)

Payer Coverage:

A review of market access for metastatic prostate cancer treatments shows that under the pharmacy benefit, about 50% of the lives under commercial formularies are covered with utilization management restrictions. Around 34% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 62% of the lives under commercial policies are covered with utilization management restrictions. Almost 67% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 95% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 12% require multiple steps. Around 74% of payer-controlled pharmacy benefit covered lives require prior authorization, with 5% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expanded Nubeqa’s Label

In August 2022, the FDA expanded the label of Bayer’s Nubeqa (darolutamide) in combination with docetaxel for adults with metastatic hormone-sensitive prostate cancer. The agency initially approved the drug on July 30, 2019. This review was conducted under Project Orbis in collaboration with Health Canada, the Singapore Health Sciences Authority, Switzerland’s Swissmedic, the United Kingdom’s Medicines and Healthcare products Regulatory Authority, and Australia’s Therapeutic Goods Administration. The review also used the Real-Time Oncology Review pilot program and the Assessment Aid. The application received priority review. The recommended dosing is Nubeqa 600 mg via two 300 mg tablets twice daily. The first of up to six cycles of docetaxel 75 mg/m² via intravenous infusion should be administered within six weeks after starting Nubeqa treatment and then every three weeks. GoodRx lists the price of 120 300 mg Nubeqa tablets as more than $11,278. Drugs.com lists the price of 10 mg/mL for two milliliters of docetaxel intravenous solution as more than $54.

FDA Approves Pluvicto

In March 2022, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as ¹⁷⁷Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope. The FDA also approved Novartis’ Locametz (gallium Ga 68 gozetotide) to identify PSMA-positive lesions in adults with mCRPC through a positron emission tomography (PET) scan. Pluvicto’s application had priority review and breakthrough therapy designation. The recommended dose is 7.4 GBq (200 mCi) intravenously every six weeks for up to six doses. The agent’s wholesale acquisition cost is $42,500 per dose.

Novartis’ Pluvicto Brings New Mechanism of Action to mCRPC Options

A new prostate cancer drug — Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as ¹⁷⁷Lu-PSMA-617) — is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights. The product offers a new mechanism of action for the indication.

Key Findings:

Market Events Drive Changes

In August 2022, the FDA expanded the label of Bayer’s Nubeqa (darolutamide) in combination with docetaxel for adults with metastatic hormone-sensitive prostate cancer. In March 2022, the agency approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as ¹⁷⁷Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

Competitive Market Landscape

Products in this drug class represent several different mechanisms of action, treating prostate cancer in different stages of the disease. Mechanisms of action include estrogen/nitrogen mustard, microtubule inhibitors, gonadotropin-releasing hormone (GnRH) analogs, autologous cellular immunotherapy, radiopharmaceuticals and androgen receptor inhibitors.

Pharmacy, Medical Benefit Implications

The products in this indication are well-reimbursed by payers. Pharmacy and medical policies may require procurement of a drug through a specialty pharmacy by either the patient or the administering doctor. On the medical benefit, providers are more often allowed to buy and bill than are required to obtain the drugs through a specialty pharmacy. For the patient, however, the oncology drugs that process through the pharmacy benefit are more often required to be obtained through a specialty pharmacy.

Key Players in Market:

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