Radar on Specialty Pharmacy

Oncologists Are Likely to Prescribe Fotivda for Advanced RCC

April 14, 2021

The renal cell carcinoma (RCC) therapeutic class boasts multiple agents, but a recent entrant is offering a new tool for certain patients. A Zitter Insights survey shows that the majority of oncologist respondents are likely to prescribe Aveo Oncology’s Fotivda (tivozanib) for advanced RCC.

On March 10, the FDA approved Fotivda for the treatment of adults with relapsed or refractory advanced RCC who have received at least two prior systemic therapies. It is the first FDA-approved therapy for this use.

NOTE: The abstract below is a shortened version of the RADAR on Specialty Pharmacy article “Oncologists Say They Expect To Prescribe Fotivda for RCC.”

By Angela Maas

The renal cell carcinoma (RCC) therapeutic class boasts multiple agents, but a recent entrant is offering a new tool for certain patients. A Zitter Insights survey shows that the majority of oncologist respondents are likely to prescribe Aveo Oncology’s Fotivda (tivozanib) for advanced RCC.

On March 10, the FDA approved Fotivda for the treatment of adults with relapsed or refractory advanced RCC who have received at least two prior systemic therapies. It is the first FDA-approved therapy for this use.

For the Managed Care Oncology Index: Q4 2020, from Dec. 2, 2020, to Jan. 5, 2021, Zitter Insights polled 40 commercial payers with 132.0 million covered lives. Payers with 84% of lives expected they would manage the drug to label, while those with 10% of lives anticipated covering it more restrictively than its label. Respondents with 6% of lives expected that they would not require prior authorization for Fotivda. None of the payers anticipated not covering the drug.

The drug’s approval was based on a handful of clinical trials, including TIVO-3, a Phase III study pitting it against Bayer’s Nexavar (sorafenib). Payers covering 40% of lives said they are likely to use Fotivda to negotiate greater discounts for Nexavar, but those with 42% of lives said they are unlikely to take that action. Those covering 78% of lives do not expect to prefer Fotivda over Nexavar in advanced RCC and do not anticipate incentivizing oncologists to prescribe Fotivda over Nexavar.

Zitter Insights also surveyed 100 oncologists during the same time frame. Almost 70% said they were likely to prescribe Fotivda for advanced RCC, as well as prescribe it over Nexavar. Respondents were fairly evenly divided on whether they would refrain from prescribing Nexavar.

In the TIVO-3 trial, points out Mesfin Tegenu, CEO of RxParadigm, “Fotivda was able to show improved progression-free survival compared to sorafenib. However, Fotivda fell short in showing overall survival relative to sorafenib. The key takeaway for Fotivda will be its safety profile relative to current therapies for RCC. Therefore, Fotivda may be an option for a subset of patients who have failed previous therapies and require a more tolerable and safe option.”

FDA’s Breyanzi Approval May Not Change NHL Management

March 8, 2021

With the FDA’s approval of Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space.

On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

NOTE: The abstract below is a shortened version of the RADAR on Specialty Pharmacy article “FDA Approval Makes Breyanzi Third CAR-T Therapy in NHL.”

By Angela Maas

With the FDA’s approval of Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space.

On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

Breyanzi joins Novartis Pharmaceuticals Corp.’s Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. unit Kite Pharma, Inc. as the three CAR-T therapies in NHL.

For the Managed Care Oncology Index: Q2 2020, between June 1, 2020, and June 30, 2020, Zitter Insights polled 51 commercial payers with 129.6 million covered lives. Those with 96% of lives anticipated that they would manage Breyanzi to label. Asked how impactful its introduction into NHL would be for their management of the indication, payers with 71% of lives said it would have either no impact or minimal impact, while 28% said it would have a moderate impact.

“All three CAR-T therapies have the same approved indication for relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy,” points out Winston Wong, Pharm.D., president of W-Squared Group. “I believe…that unless the managed care organization has a pathway program in place, there will be few organizations that will manage the selection of any of the CAR-T agents for the lymphoma indication….Since efficacy and safety appear to be similar across the three CAR-T agents, it will come down to cost.”

Breyanzi launched with a list price of $410,300 for the one-time treatment compared with $373,000 for Yescarta and Kymriah in NHL.

Wong adds that “it is my expectation that the oncology practice will be the deciding party to choose a preferred CAR-T, based upon experience and cost to the practice.”

Zitter Insights also polled 102 oncologists between June 1, 2020, and June 30, 2020. Approximately half said they did not anticipate administering Breyanzi, slightly more than those with the same response for Yescarta and Kymriah.

New Prostate Cancer Treatment Orgovyx Offers Oral Option

February 10, 2021

People being treated for advanced prostate cancer now have a new oral option. 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.

NOTE: The abstract below is a shortened version of the RADAR on Specialty Pharmacy article “Orgovyx Offers New Oral Option for People With Prostate Cancer.

By Angela Maas

People being treated for advanced prostate cancer now have a new oral option. 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.

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. Almost half of respondents indicated they are likely to transition patients on leuprolide acetate to Orgovyx.

Winston Wong, Pharm.D., president of W-Squared Group, says 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.”

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.”

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.”

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.”

FDA Approves First Oral Treatment for HAE Attack Prevention

January 12, 2021

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc’s Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

By Angela Maas

When the FDA approved BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) last month, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc’s Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.

Orladeyo will compete against Cinryze, Haegarda (C1 esterase inhibitor [human]) and Takhzyro (lanadelumab-flyo) to prevent HAE attacks.

For the Managed Care Biologics and Injectables Index: Q1 2020, between Feb. 25, 2020, and April 1, 2020, Zitter surveyed 51 commercial payers with 138.1 million covered lives about their anticipated management of Orladeyo. Payers covering 93% of lives said they likely would manage it to label and not allow off-label use.

Among 46 commercial payers with 130.3 million covered lives surveyed during the same time period, payers with 74% of covered lives said they were likely to manage Orladeyo at parity to the prophylactic therapies. And even though it is the only oral HAE drug, payers with 80% of lives said they were unlikely to manage it separately from the other drugs based on route of administration.

Among providers who would transition current patients to Orladeyo, the most likely prophylactic agent to transfer from was Cinryze, cited by 42%; followed by Haegarda, at 25%; and Takhzyro at 8%.

BioCryst has priced Orladeyo at $485,000 per person per year, which is slightly more than the $450,000 PPPY that Evercore ISI expected, according to analyst Liisa Bayko in a Dec. 4 research note. That price, though, is lower than Haegarda’s $510,000 PPPY and Takhzyro’s $566,000, she pointed out.

“As an oral, once-daily option, Orladeyo provides significant attack reduction without the burden associated with injectables — the hallmark of treatment options,” wrote Bayko. “Our market research showed that patients and physicians were eagerly awaiting an oral option, with anticipated use of Orladeyo reaching 34% of prophylaxis HAE market by [year-end] 2021 — driven by switching and growth of the market with use of prophylaxis rising from 60% to 80% over time.”

Supreme Court’s ACA Ruling May Upend Biosimilars Market

January 6, 2021

As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus has been on the people who would lose health insurance coverage and protections for pre-existing conditions if the law is overturned. Another ramification of such a ruling is that the biosimilars market could be completely upended.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created the 351(k) biosimilar pathway. After more than one attempt to get a stand-alone bill to pass, lawmakers made it part of the ACA, and it became law on March 23, 2010.

By Angela Maas

As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus has been on the people who would lose health insurance coverage and protections for pre-existing conditions if the law is overturned. Another ramification of such a ruling is that the biosimilars market could be completely upended.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created the 351(k) biosimilar pathway. After more than one attempt to get a stand-alone bill to pass, lawmakers made it part of the ACA, and it became law on March 23, 2010.

Industry observers expect a decision on the case California v. Texas by June 2021, according to various sources. And opinions among industry experts vary on what the court will decide.

“I do think it is severable, but I am optimistic that that won’t be needed,” says one industry expert who declines to be identified.

A second industry expert who declines to be identified points out that “there have been a fair amount of amicus briefings,” which will make the court “think twice” about doing away with the BPCIA.

“I think the outcome of the Affordable Care Act case before the Supreme Court will be similarly mixed as a ruling like last time,” says F. Randy Vogenberg, Ph.D., principal at the Institute for Integrated Healthcare. “I doubt they will rule the ACA is severable but will keep that door open….If the court strikes down the ACA entirely, biosimilars on the U.S. market or in the FDA approval pipeline would have to either be grandfathered in or face a regulatory wind-down.”

If the ACA and thus the BPCIA are struck down, “personally, I think it’s unlikely that medicines would be pulled off the market,” says source No. 2. However, if the ACA is invalidated, the Supreme Court likely would include “guidance to regulators for carrying out their order.”

“I would not expect FDA to de-approve anything already approved, but the pipeline might get more muddled,” says the first source.

All that said, “[g]ood business practices would recommend that biosimilar manufacturers should be preparing for the possibility of the ACA, and thus the BPCIA, being struck down,” recommends Vogenberg. “What should they be doing is scenario planning and being prepared for the best or worst and everything in between. If biosimilars are not available, this could impact payers that have them on formulary should a disruption occur in their marketing.”