Peter Wehrwein

Despite decades of research, there is still no vaccine against HIV. As a result, pre-exposure prophylaxis (PrEP) has emerged as the most promising preventive strategy against the virus that causes AIDS. PrEP is the use of antiretroviral medications by HIV-negative individuals who are at risk of contracting the disease to reduce that risk.

But the PrEP regimens have involved taking a pill on a daily basis, which makes them ripe for nonadherence.

But in on Dec. 20, 2021, the FDA approved Apretude (cabotegravir extended-release injectable suspension), the first injectable formulation of PrEP. Instead of daily pills, Apretude will involve getting an injection in the muscle of the buttock by a healthcare professional once every two months, although the first two shots are given a month apart.

“It will not be for everyone; some people may want to continue with a daily oral pill,” notes Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, an advocacy organization funded by several pharmaceutical companies. “They are fairly easy to take and there are limited side effects. People will continue to have to visit their provider for recommended periodic follow up labs and tests.”

 (tenofovir disoproxil fumarate and emtricitabine) was approved in 2012. Generic versions have come on the market since, particularly in the past year, and prices have dropped. The GoodRx’s lowest price today a 30-day supply of the most common version of generic Truvada is $35.96. What’s more, most people with private insurance do not have to pay cost sharing since it is a preventive drug approved by the United States Preventive Services Task Force.

Still, Schmid note some people may find it easier to get the injectable every two months.

“They will have to make their own decision, based on discussions with their provider, as to what is best for them,” he says. “Whatever option they choose, it is important for them to adhere to their medication as prescribed and have the periodic HIV, STI (sexually transmitted infection) and other lab tests. While PrEP protects against HIV, it does not protect against other STIs.”

The CDC says that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it in 2020, compared with about 3% in 2015. The agency credits PrEP and other factors with reducing the new HIV infections: They fell from 37,800 in 2015 to 34,800 in 2019, a decrease of 8%.

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Administered as an injection every other month, Apretude gives people at risk of contracting HIV a PrEP alternative to taking daily pills.

Injection Now Available to Help Prevent HIV

A new drug for myasthenia gravis, a rare autoimmune disease characterized by muscle weakness, might introduce some price competition among treatments used to treat the severe or refractory forms of the disease. But a report by the Institute for Clinical and Economic Review (ICER) suggests that price competition would need to be incredibly fierce for the prices to drop to levels that reflect their cost-effectiveness of the drug, The FDA approve the new treatment, called efgartigimod. Another drug for myasthenia gravis, Soliris (

, Pharm.D., a clinical pharmacist on OptumRx’s pipeline and drug surveillance, said that from a clinical perspective efgartigimod, which is being sold under the brand name Vyvgart, is unlikely to bring about big changes. “It’s not necessarily that this is going to be a paradigm shift,” Sadeghi said. “I think the efficacy is going to be similar to those other products that are currently available, but it does add some competition in this very expensive category.”

Sadeghi noted that list prices tend to mirror what is currently available but additional products can stir up competition net price — the price after rebates from manufacturers are factored in. “You might see some potential decrease in the net cost because now you have multiple players in the field,” he said in the interview with 

. Sadeghi was quick to add, though, that OptumRx’s rebates and contracting with manufacturers is out of his purview.

ICER, a well-regarded not-for-profit that conducts cost effectiveness research and issue reports, issued a report on efgartigimod and Soliris (the report uses the generic name) in October 2021.

ICER graded efgartigimod as having “moderate certainty” of having a wide range (“comparable, small or substantial”) of net health benefit when added to conventional benefit. The language was similar, but it gave Soliris a higher grade: B+ versus. C++. The report also said there is uncertainty about whether to stop either drug in patients who are responding them and if stopping is a choice, when should it be done.

But ICER’s take on the clinic effectiveness of the two drugs was less notable than its economic analysis and judgment about a fair price for both drugs based on their effectiveness and contribution to quality of life. Using some standard thresholds for cost effectiveness, ICER’s analysis concluded that Soliris’ price should range from $13,200 to $19,400, which would mean a 97%–98% decrease from its current annual cost of $653,100. The ICER analysis calculated that efgartigimod’s price should be $18,300 and $28,400.

Because Soliris is priced so high, it would be “reasonable” for payers to use the criteria used to enroll people in clinical trials of the drug in making coverage decisions rather than the FDA label, ICER said its policy recommendations. Efgartigimod doesn’t have a price yet, but it is expected to be much higher the range set by ICER, so the organization said payers should also use clinical trial criteria in shaping coverage policies for efgartigimod.

ICER was sharply critical of the pricingof Soliris, which was developed and is marketed by Alexion, a Boston company that has been acquired by AstraZeneca. The population of patients eligible for treatment with Soliris is seven times larger than the eligible population when it was first approved, the ICER report says.

“Pricing is not just a matter of cost,” says the report. “Drug prices that are set well beyond the cost-effective range cause not only financial toxicity for patients and families using the treatments, but also contribute to general health care cost growth that pushes families out of the insurance pool, and that causes others to ration their own care in ways that can be harmful.”

The FDA approved efgartigimod, which is being sold under the brand name Vyvgart and could foment price competition with Soliris (eculizumab) and other treatments usually reserved for severe or refractory cases. 

Price Competition As Result of New Drug Approval 

Two key provisions in the House “BBB “ are CMS negotiation of the prices of 10 drugs starting in 2023 and an annual out-of-pocket maximum of $2,000 for Medicare beneficiaries who buy Part D coverage.

The climate change and family leave parts of the $1.75 trillion Build Back Better legislation that passed the House on Friday grabbed most of the attention. But the gigantic bill also has a large number of provisions affecting American healthcare. Now the Senate is taking up the bill, and it’s difficult to say which of healthcare provisions will be modified — or perhaps scrapped altogether. Of course it is uncertain whether the Senate will pass a “BBB” bill. Regardless of the outcome the House bill is the starting point for the all the upper house horse trading that is getting start.

Here are 5 of the important healthcare provisions in the House Build Back Better bill:

Cap on Medicare out-of-pocket drug expenses.

 Starting in 2024, Medicare beneficiaries with Part D coverage would have a $2,000 annual limit on their out-of-pocket expenses. The bill also caps insulin costs at $35 per month.

Medicare coverage of hearing aids and other hearing services.

 Vermont Senator Bernie Sanders is pushing for Medicare coverage of dental and vision services as well as hearing aids and other hearing services. Still, hearing aid coverage is a win for Sanders, who championed Medicare for all as a candidate for the Democratic presidential nomination in 2020.

Many Democrats have wanted empower CMS to use the Medicare program’s buying power to negotiate drug prices. The House bill includes a provision that would empower the agency to the prices of up to10 drugs in 2023 and up to 20 later on.

ACA subsidies extended to the non-Medicaid expansion states.

 People without health insurance in the 12 states (most of them in are in the South) that haven’t expanded Medicare would be eligible for subsides of coverage purchased on the ACA exchanges. According to the Kaiser Family Foundation, the 2 million people could gain healthcare insurance coverage if this provision of the House bill becomes law.

Two key health provisions in the House “BBB “ would empower CMS to negotiate the prices of 10 drugs starting in 2023 and put a limit of $2,000 on Medicare Part D annual out-of-pocket costs.

"BBB" Bill Aims to Address CMS Drug Prices, Out-Of-Pocket Costs

Compared with many other countries, including the United States, Taiwan has largely avoided the high morbidity and mortality associated with the novel coronavirus disease 2019 (COVID-19) outbreak seen in other regions of the world. 

, community pharmacists were credited with helping to mitigate the spread of infections throughout the country. 

“Often serving as the first point of contact between individuals and the health care system, community pharmacists offered education and consultation on proper hygiene strategies, disseminated accurate information to counter myths and misinformation, and provided emotional support to alleviate public concerns arising from the COVID-19 crisis,” write Huang-Tz Ou, Ph.D., of National Cheng Kung University, and Yea-Huei Kao Yang, B.S. ,at the university’s School of Pharmacy.

In response to demand for personal protective equipment, community pharmacies, which are strategically located and have National Health Insurance-integrated information systems, also distributed and rationed surgical masks directly to the public to curb panic buying. 

In an opinion piece published in the Annals of Internal Medicine, community pharmacists were credited with helping to mitigate the spread of coronavirus throughout Taiwan.