Tag: Pharmacy

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Specialty drugs continue to drive Medicaid drug spending, and its getting faster, with 2021 being the first year an increase this size has been seen in overall Medicaid Rx spending.

 
 

 
 

 
 

Clipped from: https://www.managedhealthcareexecutive.com/view/medicaid-net-drug-spend-hits-double-digits-for-the-first-time-says-magellan-rx-report

Spending on specialty drugs fueled a 11% increase in Medicaid drug spending from 2020 to 2021, says Magellan’s seventh annual Medicaid Pharmacy Trend Report.

Net Medicaid drug costs increased by 11% from 2020 to 2021, according to Magellan Rx Management’s Medicaid Pharmacy Trend Report, which was published earlier today. It is the first time during the seven-year history of Magellan’s report on Medicaid drug expenditures trend that the increase has been in the double digits, according to the report.

As is true for drug spending for almost all payers, specialty drugs — expensive drugs for rare disease — are accounting for a growing share of Medicaid drug spending and the year-to-year increases in spending, or “trend,” according to the Magellan.

Source: Magellan Rx Management Medicaid Pharmacy Trend Report, 7th edition

The report says the specialty net trend rose 2.1 percentage points from 10.9% in 2020 to 13% in 2021 while the traditional net trend rose 4.1 percentage points from 1.9% to 5.8%. In 2021, specialty drugs accounted for small fraction of drug claims — just 1.3% — but for the majority — 53.8% — of the net drug costs, according to the Magellan report. That is a 2.3 percentage point increase from 2020 when specialty drugs accounted for 51.5% of total net drug costs.

Net costs are often used analysis and calculations of Medicaid drug costs because the difference between the gross and net spending is so large. Medicaid programs receive in a mandatory 23.1% rebate from manufacturers and additional rebates for many drugs on top of that mandatory rebate. According to the Magellan’s numbers, the net cost per claim in 2021 was $58.55, or just 41% of the gross cost per claim of $142.18.

Magellan’s report is not based on drug prices and spending for all Medicaid programs. Rather, the report is based on data for the company’s fee-for-service pharmacy programs in 24 states and the District of Columbia. The report says the data set used to prepare this report included 95 million claims with a gross cost of $13.6 billion and a net cost of $5.6 billion.

Late last year, Prime Therapeutic finalized the $1.35 billion acquisition of Magellan Rx, the pharmacy division of Magellan Health, from Centene Corporation.

The report identifies the specialty drugs most responsible for the increase in spending on specialty drugs. Topping the list are Hemlibra (emicizumab), a treatment for hemophilia A treatment; Trikafta (elexacaftor, tezacaftor, and ivacaftor), a treatment for cystic fibrosis; Evrysdi (risdiplam), a treatment for spinal muscular atrophy; Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide, an HIV treatment; and Stelara (ustekinumab), a treatment for plaque psoriasis, Crohn’s disease and ulcerative colitis.

The report also ranks 50 drug classes by their share of the net spend in 2021. Drugs for HIV/AIDs ranked the highest, accounting for 10% of the net Medicaid spend in 2021. They were followed by antipsychotics (8.4%), hemophilia treatment (7.2%), anticonvulsants (6.3%), oral cystic fibrosis drugs (5.6%) and cytokine and CAM (cell adhesion molecule) antagonists (4.3%), a group that includes Stelara and Humira (adalimumab).

Source: Magellan Rx Management Medicaid Pharmacy Trend Report, 7th edition

Drugs for spinal muscular atrophy, a group of inherited diseases that damage and destroy motor neurons, was further down on the list, ranking 13th and accounting for 1.5% of the net spend. But the report says that claim volume increased by 425% as prescriptions for Evrysdi increased and the market share of Spinraza (nusinersen), delivered via an intrathecal injection, shrank.

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: Medicaid spent $25B on HIV drugs over a 12 year period, and the researchers try to figure out what drove increases.

 
 

Clipped from: https://www.infectiousdiseaseadvisor.com/home/topics/hiv-aids/medicaid-spending-antiretrovirals-increased-between-2007-2019/

Medicaid spending on antiretroviral therapies (ARTs) used to treat human immunodeficiency virus (HIV) increased by 178% between 2007 and 2019, according to study findings published in Clinical Infectious Diseases.

Researchers at Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts, sought to estimate Medicaid spending on ARTs to treat HIV between 2007 and 2019. They obtained publicly available data on Medicaid State Drug Utilization, and approximated Medicaid’s net spending based on average prices and Medicaid rebates for 48 available ARTs. The base Medicaid rebate ranged from 15% to 23% plus any added rebates if the medication’s price increased faster than inflation.

According to the researchers’ estimates, Medicaid spent around $25 billion for 17 million 30-day supplies of the 48 available ARTs between 2007 and 2019.

When comparing 2007 spending to 2019 spending, Medicaid’s annual net spending increased by 178% from $1.1 billion to $3.0 billion, while the average net price of ARTs increased 28% from $1432 to $1830 for every 30-day supply. Annual use of ARTs increased 118% from 700,000 to 1.6 million 30-day supplies during the same period. These increases suggest that newer ART formulations, combinations, and ingredients were more expensive, and that inflationary rebates did not effectively counteract rising costs.

Other factors may also explain the rising spending on ARTs. The population of Medicaid beneficiaries increased, particularly following the passage of the Affordable Care Act, which expanded Medicaid eligibility in 2012. Treatment advancements and improved efficacies also extended the lifespan of individuals living with HIV.

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[T]he US government should be authorized to assure that launch prices for new drugs covered by Medicaid are aligned with the added benefit they offer over existing therapies.

In 2007, the most commonly used ARTs included TVD, EFV/FTC/TDF, and LPV/r. In 2019, the most commonly used ARTs consisted of single-tablet regimens, including BIC/F/TAF, E/C/F/TAF , and DOL/ABC/3TC.

Limitations of the study include possible underestimation of actual rebates, use of estimated ART prices and estimated medication usage based on 30-day supplies of medications.

“Medicaid spending on [ARTs] nearly tripled from 2007-2019, due to expanded use of [ARTs] and rising prices,” the study authors conclude. They add, “To prevent sustained high prices due to serial replacement of brand-name drugs with incrementally different products among [ARTs] and other classes of drugs, the US government should be authorized to assure that launch prices for new drugs covered by Medicaid are aligned with the added benefit they offer over existing therapies.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

 
 

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: The author wants to be ticked about expansion but also wants to benefit from the idea that lockdowns caused a surge in MH needs. Besides all that we get some decent data on MH drug trends in Idaho.

Clipped from: https://idahofreedom.org/mental-health-declines-as-medicaid-funds-record-psychotropic-drug-use/

 
 

 
 

Taxpayer-subsidized government healthcare is not making people healthier. 

New data shows that the use of psychotropic drugs among Medicaid beneficiaries is projected to reach an all-time high for the third consecutive year. With one in every five Medicaid prescriptions in Idaho written for these drugs, there exists a serious problem with mental health throughout the Gem State.

Psychotropic drugs are generally used to treat mental health conditions like anxiety, depression and mood disorders. In 2016, there were just under 400,000 claims for such medications. Since then, the use of these drugs has increased significantly, with claims growing 86% as of 2021.  Estimates for 2022 say that Idaho Medicaid will spend $91 million to cover just short of one million claims for psychotropics by the end of the year.

Figure 1

Medicaid expansion and the COVID-19 pandemic both started in early 2020, as did the steep increase in psychotropic use. In the previous decade, spending on psychotropic medications declined by 5% per year and the number of prescriptions declined by 1% per year, when adjusted for inflation and Medicaid enrollment. Since 2020, however, this decline suddenly became a sharp annualized increase of 6% in prescriptions and 15% in spending (see Figure 2). 

Figure 2

Medicaid expansion added to the number of people who could receive benefits. But that change alone does not explain the rapid increase in prescriptions and prescription expenses. Demographic changes played a key role.

The effects of the pandemic – exacerbated by harsh government policies, including Gov. Brad Little’s statewide lockdowns – created a surge of Idahoans applying for Medicaid. For adults under 40 and those in their 60s, lockdown policies created isolation, unemployment, and economic hardship, all of which harmed their mental health significantly more than was the case for all other age groups. This likely generated a demographic shift necessary, among both existing and new Medicaid enrollees, that accounts for the sudden rise in psychotropic drug use. Despite the state’s relatively quick economic recovery touted by the governor, these concerning trends remain and are worsening.

There is cause for skepticism about the efficacy of prescribing psychotropic drugs to treat mental health conditions. One groundbreaking study asserts that the foundational theory supporting antidepressants – the chemical imbalance theory – is incorrect. Naturally, this research also calls into question whether antidepressants are effective forms of treatment. This theory has also been the basis of hesitancy for doctors and patients to stop antidepressant treatments, leading to lifelong use by people who would otherwise be able to seek better alternatives.

Despite doubts about the efficacy of some psychotropics, like antidepressants, these types of drugs are still commonly overprescribed. A national study notes that three out of every five visits where a new psychotropic drug was prescribed to a patient had no corresponding psychiatric diagnosis. Not only is this practice potentially detrimental to patient health, but the same study links this over-prescription to rising costs within the Medicaid system.

This tendency to overprescribe psychotropic drugs also made it common for patients to be taking more than one of these medications at the same time. Disturbingly, patients on Medicaid are significantly more likely to be taking multiple psychotropic drugs, despite this being an ill-advised practice that could have harmful effects on patients. This is especially concerning for the case in Idaho, as the state ranks among those with the highest incidence of this practice.

What is happening within the Medicaid system is an example of how government control negatively impacts people’s lives. The big government policies that dictated how we weathered the pandemic destroyed the livelihoods of many Idahoans and had long-term negative effects on their health and freedom. 

The entrapment of patients in chronic therapies is a common convention of modern medicine. Guaranteeing that patients continue their treatments without the hurdle of paying for them – as the Medicaid system does so well – is good for business among medical interest groups. Some healthcare professionals are beginning to notice these practices, resulting in the increasing popularity of osteopathic physicians versus their allopathic counterparts – that is, DOs rather than MDs. Scholars are finding that not only are mental health conditions not treated well with medications, but lifestyle plays a greater role in mental health than originally thought, and the medical community is beginning to take note.

Patients should be weary of those claiming to advocate for their well-being, only to call for bigger government and more social programs. Like subsidies and bailouts to support companies that are failing due to their bad business models, Medicaid is subsidizing the use of healthcare treatments and practices that may not be best for patients. However, the consequences of doing so are more severe than traditional business bailouts and the result is a worse healthcare system for everyone.

MM Curator summary

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

[MM Curator Summary]: A move to mail-order pharmacy for oncology drugs has very few fans.

 
 

 
 

Save Our Access, Save Our Lives Rally takes place on October 12

ALBANY, N.Y. (NEWS10) — There will be a Save Our Access, Save Our Lives rally on October 12 at 2 p.m. where The New York Oncology Hematology (NYOH) will call on the New York State Department of Health (NYSDOH) and state leaders to reverse a policy that has left Medicaid patients without access to life-saving cancer care medication.

NYOH will be joined by partner organizations, community leaders, and elected officials as they advocate for Medicaid recipients to regain access to life-saving oral cancer care medications through physician dispensaries. The rally is asking for support from legislators and representatives that can help resolve this problem for patients. Director of Pharmacy & Admixture Services for NYOH, Nancy Egerton comments on the situation by saying she’s “glad to have such a diverse group of people attending this rally.” Egerton hopes the outcome of this event is a positive resolution.

The New York State Department of Health (NYSDOH) made a policy change to their Medicaid Pharmacy Program that prevents Medicaid patients from obtaining their oral medications through their physician dispensary. This forces patients to receive their oral cancer medication prescriptions from a mail-order pharmacy, adversely affecting cancer patients’ care. According to the NYSDOH website, beginning in April 2023, all Medicaid consumers enrolled in Mainstream Managed Care will receive their prescription drugs through the Medicaid Fee-For-Service (FFS) Pharmacy Program. The FFS Program will allow NYS to pay pharmacies directly for the drugs and supplies of Medicaid consumers. The NYSDOH notified patients on September 1 leaving patients under Medicaid-managed care to try and go to an alternate source than their physician. The mail-order pharmacy creates problems and long waits for needed medication.

The NYOH are not considered a pharmacy but a dispensary not allowing patients to get their prescriptions filled at NYOH. The NYOH approached the NYSDOH about two years ago asking to be enrolled as a dispensary and allowing patients to get their prescriptions. August of 2022, the NYOH was informed that this enrollment was not going to happen.

Biden will order HHS to consider using Medicaid to support women seeking abortions across state lines

The rally will take place on October 12 at 2 p.m. at the West Capitol Park, 85 Swan Street, Albany. Many people such as Sabrina Mosseau, Executive Director, New York Oncology Hematology; Nancy Egerton, pharmacy manager, New York Oncology Hematology; representative from National Community Oncology Dispensing Association (NCODA); representative for Assemblymember Jake Ashby; representative for Senator Zellnor Myrie will be in attendance.

 
 

Clipped from: https://www.news10.com/news/albany-county/nyoh-calls-on-nysdoh-to-reverse-medicaid-policy-change/

[MM Curator Summary]: You can have faster cancer drugs or cost management. Not both.

 
 

The article below has been highlighted and summarized by our research team. It is provided here for member convenience as part of our Curator service.

 
 

 
 

 
 

An Oregon proposal to exclude expensive drugs that received FDA fast-track approval from Medicaid coverage is alarming advocates for patients with cancer and other life-threatening diseases.

If approved, the proposal could limit access in Medicaid to promising treatments for patients with deadly conditions, and could encourage other states to similarly attempt to restrict access to get relief from rising drug costs, advocates say.

At issue are drugs approved under the Food and Drug Administration’s accelerated approval pathway, which emerged in the 1990s during the AIDS crisis as a way of speeding access to medications for patients with serious conditions and few, if any, treatment options. The pathway has gained renewed attention from lawmakers after the FDA approved Biogen Inc.’s Alzheimer’s drug Aduhelm against the recommendation of its scientific advisers.

Accelerated approval drugs can be very expensive—many of them over $10,000 per month—and many more are in the pipeline, according to Matt Salo, executive director of the National Association of Medicaid Directors. The Oregon proposal is a sign that states are worried about how they’ll pay for such treatments, he said.

Other states will be watching the response of the Centers for Medicare & Medicaid Services to the Oregon proposal “very closely,” Salo said.

Annual Medicaid spending on accelerated approval drugs increased from $728 million in 2015 to $1.44 billion in 2020, and the percentage of program spending that went to such drugs increased from 2.3% to 4.2%, according to a 2021 study in Health Affairs.

Confirmatory Trials

Drugmakers ordinarily must show that their products produce a benefit through lengthy and costly clinical trials to win approval—meaning a favorable effect on how a patient feels, functions, or survives.

Accelerated approval removes the requirement to run clinical trials upfront. Instead, drugs are approved based on their effect on a “surrogate endpoint,” an objective indication thought likely to lead to a clinical benefit.

The result has been quicker approval of promising drugs. But Oregon’s proposal zeroes in on a frequent criticism of the accelerated approval pathway: that it removes pressure on drugmakers to run the clinical trials that are needed to show that their products do, in fact, produce a clinical benefit.

The Oregon proposal is part of the state’s application to renew and amend its Section 1115 waiver, referring to special conditions under which it runs its Medicaid program.

Section 1115 is a part of the Social Security Act that deals with Medicaid and allows the secretary of the Department of Health and Human Services to waive program requirements to allow states to test new approaches to coverage and payment.

Oregon’s current waiver is set to expire June 30. The federal comment period on the renewal proposal closed April 7.

Current Medicaid regulations generally require states to cover all drugs that have been approved by the FDA, including where the drugmaker subsequently fails to show clinical efficacy within the timelines that were imposed as a condition of accelerated approval, the Oregon renewal application said.

In return for guaranteed Medicaid coverage for their FDA-approved drugs, drugmakers are required to pay large rebates to the states. Medicaid spent about $64 billion on outpatient prescription drugs in 2017, and collected $34.9 billion in rebates, resulting in net spending of $29.1 billion, according to the Medicaid and CHIP Payment and Access Commission.

Allowing Oregon to exclude accelerated approval drugs would give drugmakers an additional incentive to complete the required clinical trials, and would ensure that states are paying only for drugs that have been proven to provide a clinical benefit, Oregon said.

That is not always the case under the current system, said Rachel Sachs, a professor at the Washington University School of Law.

“There are cases where a drug manufacturer completes the confirmatory trial on a drug that has received accelerated approval, the trial fails, and the drug stays on the market,” Sachs said. “And the FDA either can’t or won’t remove it. And that raises an important question: should the states and the taxpayers have to spend their limited resources on a product that has no demonstrated evidence of clinical benefit?”

Cancer Drugs

But those who look at the issue of accelerated approval drugs from the standpoint of patients rather than of the Medicaid program as a whole ask a different question: whether it makes sense to allow states to restrict access to lifesaving drugs for low-income patients in the name of cost savings.

“This is a matter of incredible importance for cancer patients,” said Mark Fleury, a principal on the policy development team at the American Cancer Society. “Oncology makes up the lion’s share of accelerated approvals for all drug types, and within oncology, the majority of new molecular entities that have been approved over the past three years have been via accelerated approval.”

The impact on drug availability for patients who have no other treatment options have been dramatic, he said. The accelerated approval process has reduced the time for drugs to hit the market by 3.4 years on average.

“For cancer patients, that can make all the difference,” he said. “This process really is working. It really is granting patients earlier access to life-extending and lifesaving treatments.”

Policy Proposals

The problem with the Oregon proposal is that its target is the drug companies but its victims are Medicaid enrollees in need of accelerated approval drugs, said Wayne Turner, a senior attorney in the National Health Law Program.

“This isn’t a problem for the individual states to handle through the Section 1115 waiver program,” Turner said. “This is a matter for Congress.”

A variety of policy proposals have surfaced in Congress aimed at reforming the accelerated approval pathway and pressuring drug companies to complete confirmatory clinical trials.

These include allowing the FDA to take quicker action to remove drugs from the market once they have failed to demonstrate clinical benefit, requiring drugmakers to provide a plan for confirmatory trials before obtaining accelerated approval, increasing reporting requirements related to confirmatory trials, and imposing fines on drugmakers that fail to complete the trials.

A proposal floated by MACPAC would require drugmakers to pay increased rebates for accelerated approval drugs.

But looming in the background is a more fundamental issue for Congress to address, said Salo: how to help state Medicaid programs pay for an expected flood of expensive new treatments in the coming years.

“There’s a whole world of new therapies coming our way, we’ve really made it a national priority to go ‘all in’ on innovation, but we haven’t had the follow on conversation about the cost of innovation, and how we’ll pay for it,” he said.

“You’d find a lot of agreement from the states about this: we’re probably going to need help from our federal partners to spread the cost out more broadly.”

 
 

Clipped from: https://news.bloomberglaw.com/health-law-and-business/new-cancer-drug-access-at-risk-in-oregon-medicaid-proposal