Orgovyx Offers New Oral Option for Prostate Cancer

People being treated for advanced prostate cancer now have a new oral option, offering patients the ability to not have to visit a provider for administration — an especially welcome alternative during the COVID-19 pandemic. Industry experts point to an array of reasons as to why the new drug should expect to get a lot of use. And a recent Zitter Insights survey indicates that the majority of oncologist respondents likely will prescribe it, with many saying they expect to favor it over the current standard of care.

On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer. Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

Treatment of advanced prostate cancer usually involves androgen deprivation therapy (ADT), and the current standard of care is luteinizing hormone- releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, which is administered by a health care provider as an injection or implant. It is available as AbbVie Inc.’s Lupron Depot and Eligard from Tolmar Pharmaceuticals, Inc. to treat prostate cancer. Dosing options are 7.5 mg every month, 22.5 mg every three months, 30 mg every four months or 45 mg every six months.

For the Managed Care Oncology Index: Q3 2020, between Aug. 26, 2020, and Sept. 30, 2020, Zitter surveyed 50 commercial payers about their anticipated management of Orgovyx within six months of availability. Those with 89% of covered lives said they were likely to manage the drug to label.

During the same time frame, Zitter surveyed 100 oncologists, and 77% said they were likely to prescribe Orgovyx, with 62% saying they were likely to prescribe the new drug over leuprolide acetate (see chart, p. 7). Almost half of respondents indicated they are likely to transition patients on leuprolide acetate to Orgovyx.

Oral Option Is Helpful During Pandemic

Noting that the new drug will allow patients to avoid some visits to a clinic for treatment, Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement that “this potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

Winston Wong, Pharm.D., president of W-Squared Group, tells AIS Health that he expects Orgovyx to have “significant uptake for several reasons. Even though it is taken daily, it is easier for the patient to be treated when compared to the patient having to travel to the physician office to receive their injection.” This is particularly true during a pandemic, when “minimal office exposure is preferred, and oral regimens support the social distancing recommendations. We see this in the oncology arena where there is a preference towards oral regimens, even if the regimen is not as effective as the intravenous option.”

He acknowledges that providers will be “losing out on the revenue from the drug markup, the avoided office visit and the administration. But again in these days of the pandemic, it is the new accepted norm.” He says he expects prescriptions to drop for Lupron and Eligard. “Possibly the remaining niche for either of these injectable drugs would be for the traditional Medicare patient who does not have a prescription plan through Part D or a Medicare Advantage plan. In these cases, the injection is the only viable option as a covered benefit.”

Avoided MD Visits Provide Savings

For payers, Orgovyx, he says, “is approximately 25% less expensive from a drug cost standpoint, charges for office visits and administration are avoided, and utilization of the oral product is more easily monitored being covered under the prescription benefit.”

Myovant has set Orgovyx’s monthly price at $2,313. Based on CMS’s average sales price, that “is less costly than the reimbursement of $1,582 per 3.75 mg dose increment,” says Wong. “No matter whether the dose of leuprolide is given every month, every three months, every four months or every six months, the monthly cost remains constant at $3,164 per month. The cost effectiveness of Orgovyx from just the medication cost perspective is realized. On top of the cost difference of the medication, there is savings from cost avoidance of the office visit and the administration cost. The final cost consideration is the member liability, which will more than likely be higher with the oral product since it will fall under the prescription benefit as opposed to the member liability under the medical benefit, except in states that have oral parity regulations in place.”

According to Bill Sullivan, a longtime industry expert, “since it is an oral tablet, there would be a preference [among payers] to cover it, as it would go through the PBM, opening the door for rebates to flow to them vs. the physicians. Additionally, the payer might possibly eliminate the cost of an office visit just for an injection.”

During a Dec. 21 conference call to discuss the drug’s approval, then-Myovant CEO Lynn Seely, M.D., noted that “two out of three men with prostate cancer have cardiovascular risk factors, and an estimated 30% of prostate cancer patients have diagnosed disease. In fact, more men with prostate cancer die of cardiovascular disease rather than from prostate cancer. Notably, injectable LHRH agonists as well as other prostate cancer medicines may increase the risk of cardiovascular events. The urology and oncology communities are beginning to recognize this troubling reality, and [it] is one of the main reasons why the development and launch of Orgovyx is so important for patients with advanced prostate cancer.”

Seely, who stepped down earlier this year, also noted that injectable LHRH agonists “are associated with mechanism-of-action limitations, including an initial surge in testosterone levels that can exacerbate clinical symptoms,” resulting in a delay until testosterone is suppressed and prostate-specific antigen (PSA) levels are reduced. They also are “associated with delayed testosterone recovery when discontinued.”

Orgovyx, she said, does not cause these responses. In addition, men in the Phase III HERO study who received Orgovyx “had a lower incidence of major adverse cardiovascular events, including heart attacks, strokes and death from any cause, compared to those receiving leuprolide injections, all with one pill once a day.”
During the call, Adele Gulfo, Myovant’s interim chief commercial officer, noted that the company had been focused on educating physicians, urologists and payers about Orgovyx for months. In addition, it had hired 100 sales professionals with urology and oncology experience, as well as provider relationships, in preparation for a virtual launch targeting the 10,000 physicians who write most of the prescriptions for ADT.

Also expected to help with the rollout is a deal revealed shortly after Orgovyx was approved, on Dec. 28: Myovant is working with Pfizer Inc. to develop and commercialize the drug in both prostate cancer and women’s health, specifically uterine fibroids and endometriosis.

Myovant has tapped two specialty pharmacies, Biologics by McKesson and US Bioservices, to fulfill prescriptions and provide services directly to patients. The company also is making Orgovyx available for in-office dispensing pharmacies and specialty pharmacies in hospital, academic and institutional sites. The authorized specialty distributors are ASD, Besse, Cardinal Health Specialty Distribution, CuraScript SD, McKesson Plasma & Biologics, McKesson Specialty Health and Oncology Supply.

Will Large Practices Dispense Drug?

“We estimate approximately 60% of large group practices currently have in-office dispensing capabilities, and that proportion continues to grow year over year,” said Gulfo. “We expect these practices will generate the majority of Orgovyx volume.”

However, says Wong, those practices will still have to acquire the drugs from the specialty distributors, “which will take away most of the margin to the office and pharmacy. They would also need to process the claim to the PBM as they do now.…I don’t think in-office or hospital specialty pharmacies will dispense unless they can make money on it. I doubt they will do it out of pure convenience to the patient, especially if the PBM limits the days’ supply.”

The fact that providers have been buying and billing for therapies in this class will influence Orgovyx’s uptake, contends Sullivan, who points to “many other similar competitive launches for in-office administered drugs. Physicians will stay with the established therapies until they evaluate what net-net pricing will be, including any discounts or rebates for which they may be eligible.”

Asked about gross-to-net discounts, Gulfo declined to offer specifics. Frank Karbe, president and chief financial officer of Myovant, noted during the call that as an oral product, Orgovyx will be managed under the pharmacy benefit, while the provider-administered ADT products fall under the medical benefit. “The discounting dynamics between the two are quite different. And consequently, we expect the Orgovyx gross-to-net discount on average to be significantly lower than what it is for Lupron.”

Ultimately, maintains Wong, “I foresee payers definitely covering it for all of the reasons previously stated: less expensive medication, no office visit or administration costs, prescription benefit access and benefit administration, and tighter control.”

For more information on the Zitter data, contact Jill Brown Kettler at jbrown@aishealth.com. Contact Sullivan at bsullivan0011@gmail.com and Wong at w2sqgroup@gmail.com.

This story was reprinted from AIS Health’s monthly publication RADAR on Specialty Pharmacy. Visit https://aishealth.com/product/specialty-pharmacy.