Product Release

Trends That Matter for MCO’s Role in COVID Vaccine Rollout

January 14, 2021

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

Health care workers and nursing home residents have been designated by the Centers for Disease Control and Prevention as the first group (phase 1a) to receive the vaccine.

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

Health care workers and nursing home residents have been designated by the Centers for Disease Control and Prevention as the first group (phase 1a) to receive the vaccine.

“I think the paradigm of changing tires on a moving bus applies to this venture,” remarks Margaret Murray, CEO of the Association for Community Affiliated Plans (ACAP). “We certainly support the idea of getting the vaccine to front-line health care workers and the very most vulnerable populations, such as nursing home residents, first. So CDC is off to a good start.”

But ACAP, which is composed of 77 not-for-profit safety net health plans covering Medicaid, marketplace and MA enrollees, is concerned about other vulnerable seniors — such as those who are very frail or homebound and likely dual eligible — who are not part of that first round. “We need to think about them in the next wave,” Murray tells AIS Health via email. “We also need to consider how most equitably to distribute the vaccine.”

In a preliminary analysis — or snapshot — of fee-for-service Medicare claims and Medicare Advantage encounter data from Jan. 1 to Sept. 12, 2020, CMS reported 1.19 million COVID-19 cases and 332,672 related hospitalizations among all 62.3 million beneficiaries. That’s a rate of 517 hospitalizations per 100,000 lives. The data puts into stark clarity what is already suspected about the virus: those at the highest risk of developing severe complications are older, lower income, have preexisting conditions and (with the exception of Asian beneficiaries) are more likely to be racial minorities.

Radar On Market Access: 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, AIS Health reported. 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.

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, AIS Health reported. 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.”

Perspectives on New-to-Market Oral Drugs

January 7, 2021

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA, AIS Health reported. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

Take roxadustat, which if approved would be the first novel therapy for chronic kidney disease-related anemia since 1989 and would offer an oral alternative to the injectable erythropoiesis-stimulating agents (ESAs) currently being used to treat the condition.

“Dialysis-dependent patients usually get their ESAs administered with dialysis via IV infusion, so the oral alternative in these patients doesn’t provide a convenience benefit necessarily,” says Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx. “However, there may be alternative benefits around safety.”

Then there’s Orladeyo (berotralstat), BioCryst Pharmaceuticals, Inc.’s treatment for hereditary angioedema (HAE) attacks. When the FDA approved Orladeyo on Dec. 3, it became the first oral plasma kallikrein inhibitor for the prevention of HAE attacks, Dreitlein says.

“The convenience benefit for berotralstat would have been more significant,” he says, but the 2018 approval of approval of Takhzyro, which is subcutaneously administered every two to four weeks and can be self-administered, “diminishes that because it already reduced the number of injections vs. older C1 concentrate products.”

The FDA on Dec. 18 approved relugolix, the first oral GnRH receptor antagonist on the market for advanced prostate cancer.

Relugolix’s oral administration gives it an advantage over Firmagon (degarelix), which requires monthly subcutaneous injections by a health care provider “and hasn’t garnered much commercial success because of the frequent injections and injection site reactions,” Dreitlein says.

The more common GnRH receptor agonists, on the other hand, require intramuscular injections at intervals ranging from one to six months. “Compared to these drugs, relugolix might confer some clinical advantages, but the convenience benefit is reduced because you are replacing an injection given potentially every six months with an oral daily medication,” Dreitlein adds.

Radar On Market Access: Despite New Approvals, Plans Still Favor Generics for Epilepsy

January 5, 2021

Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders tell AIS Health.

Xcopri (cenobamate tablets), manufactured by SK Biopharmaceuticals Co., Ltd.’s subsidiary SK Life Science, Inc., launched in May for the treatment of partial-onset seizures. However, many plans haven’t jumped to add Xcopri to their formularies, says Mesfin Tegenu, R.Ph., president of PerformRx.

Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders tell AIS Health.

Xcopri (cenobamate tablets), manufactured by SK Biopharmaceuticals Co., Ltd.’s subsidiary SK Life Science, Inc., launched in May for the treatment of partial-onset seizures. However, many plans haven’t jumped to add Xcopri to their formularies, says Mesfin Tegenu, R.Ph., president of PerformRx.

“Some plans have opted to take a cautious approach and leave the medication as non-formulary to start,” Tegenu says. “It is difficult to tell the impact of this new drug launch on the treatment of epilepsy. However, Xcopri trials demonstrated high efficacy in partial onset seizures and refractory epilepsy, lending it a strong clinical profile. One could reasonably suspect a high impact on the epilepsy treatment paradigm.”

In most cases, though, generics are the first-line treatments for many forms of the disorder, according to Tegenu. Many of the drugs used to treat epilepsy are covered without restriction by plans.

Prime Therapeutics LLC treats Xcopri as a non-preferred brand, says April Kunze, senior director of clinical formulary development and trend management strategy for the PBM. Premera Blue Cross’ Medicare Advantage formularies, Cigna Corp.’s national preferred formulary and HealthPartners’ commercial formularies impose quantity limits on Xcopri, according to their plan documents.

“Treatment is based on the type of epilepsy diagnosed, and labeled and off-label indications of the individual products. There is a fair amount of overlap as many drugs share multiple indications. However, many newer agents are narrowly indicated,” Tegenu says.

In November 2018, GW Pharmaceuticals launched its product Epidiolex (cannabidiol), a much-anticipated new drug for two rare forms of childhood epilepsy. In August, the FDA expanded indications for Epidiolex to include seizures associated with tuberous sclerosis complex in patients age 1 or older.

“Based on previous positive trial results in TSC patients, Epidiolex may become an important treatment option for patients,” Elizabeth Thiele, M.D., Ph.D., director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, said in a statement when the FDA widened Epidiolex indications.

For his part, Tegenu expresses some skepticism about the drug. “Epidiolex represents another option for treatment of Lennox-Gastaut and Dravet syndrome,” Tegenu says. “However, its efficacy hasn’t shown significant improvement relative to existing treatments.”

Trends That Matter for COVID Vaccine Distribution

December 31, 2020

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer, AIS Health reported.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer, AIS Health reported.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

“We might be able to put a puzzle together that an individual provider or group may not have,” she said during a Nov. 18 National Institute for Health Care Management (NICHM) Foundation webinar. “Data from many sources should be used to ensure those who are most vulnerable are ID’d per federal and state guidelines. We can see where folks have seen three different doctors, used telehealth and gone to urgent care.”

In addition, health plans are more likely than providers to have better data about whether individuals have received each of their vaccine doses. That’s because states may expand the scope of the type of providers that can administer vaccines in an effort to broaden access.

While multiple vaccines appear ready to come to market, health plans do have some concerns. According to a recent Avalere Health survey of 39 U.S. health plans and one PBM, collectively representing about 48 million covered lives, the effectiveness of vaccines and therapeutics is the top COVID-19 concern for more than 47% of health plans.

Radar On Market Access: MCO Messaging Plays Key Role in COVID Vaccine Rollout

December 24, 2020

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

States and the federal government recently began rolling out the COVID-19 vaccine to health care workers across the country. Health plans, particularly those that serve high-risk individuals, may be ideally situated to coordinate care and update members on vaccination opportunities, experts tell AIS Health.

The FDA on Dec. 11 authorized emergency use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech in individuals age 16 and older. Then the agency on Dec. 18 authorized Moderna’s vaccine for emergency use in people 18 years or older.

Health care workers and nursing home residents have been designated by the Centers for Disease Control and Prevention as the first group (phase 1a) to receive the vaccine.

“I think the paradigm of changing tires on a moving bus applies to this venture,” remarks Margaret Murray, CEO of the Association for Community Affiliated Plans (ACAP). “We certainly support the idea of getting the vaccine to front-line health care workers and the very most vulnerable populations, such as nursing home residents, first. So CDC is off to a good start.”

But ACAP, which is composed of 77 not-for-profit safety net health plans covering Medicaid, marketplace and MA enrollees, is concerned about other vulnerable seniors — such as those who are very frail or homebound and likely dual eligible — who are not part of that first round. “We need to think about them in the next wave,” Murray tells AIS Health via email. “We also need to consider how most equitably to distribute the vaccine.”

“Hopefully, this will start to evolve quickly, but there’s yet a lot to be figured out,” concurs Cheryl Phillips, M.D., president and CEO of the SNP Alliance, pointing out that there is no mechanism for tracking who has and who hasn’t received the vaccine. The plans that are most likely to serve some of the high-risk older adults that will soon qualify for the vaccine are MA Special Needs Plans, she says, “and they can be a wonderful partner for data sharing and working with providers,” as well as communicating with members to help them get the vaccine.

Murray adds messaging from plans will be crucial, especially if members are skeptical of the vaccine or behind on their vaccines in general.