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Pharmacies accuse D.C. of threatening AIDS drug program

Health director says HIV patients will get drugs on time

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gay news, Washington Blade, Truveda, PrEP, HIV

A decision by the D.C. Department of Health to terminate its contract with a local pharmacy chain that has administered the city’s AIDS Drug Assistance Program, or ADAP, could prevent patients who rely on the program from refilling their prescriptions after July 1. (Photo by Dvortygirl via Wikimedia)

A representative of at least 15 D.C. pharmacies dispensing prescription drugs for low income people with HIV and AIDS and the director of the city’s Department of Health gave conflicting views this week on whether patients’ ability to refill their prescriptions for life-saving AIDS drugs will be disrupted beginning July 1.

A decision by DOH to terminate its contract with the local pharmacy chain Care Pharmacies that has administered the city’s AIDS Drug Assistance Program, or ADAP, was expected to prompt an as yet undetermined number of pharmacies to discontinue serving ADAP patients, potentially preventing the patients from obtaining the drugs when their current prescriptions run out, according to pharmacist Michael Kim, owner of Grubbs Pharmacy.

“This is going to be an absolute disaster,” said pharmacist Tamara Foreman, a member of the D.C. Board of Pharmacies, an independent entity that advises the city on pharmacy related matters.

“The patients are not being notified,” said Foreman, who also serves on the board of a non-profit organization that advocates on behalf of pharmacy patients. “They are being told to anticipate a gap in service, but they’re not being told where to go if their pharmacy stops filling their prescription.”

Dr. Mohammad Akhter, director of the DOH, and Dr. Gregory Pappas, director of DOH’s HIV/AIDS, Hepatitis, Sexually Transmitted Disease, and Tuberculosis Administration (HAHSTA), strongly dispute that assessment. Both told the Blade that no ADAP patients will be adversely impacted by the pharmacy related changes DOH is putting in place.

“We are providing the patients with a 60-day supply of drugs during the transition period,” Akhter told the Blade on Wednesday at a news conference on the release of the city’s 2011 Annual Report on its efforts to combat HIV/AIDS.

“I can tell you that no patients will be harmed in any way,” said Akhter.

He said DOH recently decided to postpone for one month the implementation of the revamped ADAP pharmacy program.

But he and Pappas declined to disclose how many pharmacies involved in the existing ADAP program operated by Care Pharmacies and how many others have opted to join the revised program to be operated directly by DOH.

Some AIDS activists, including Patricia Hawkins, a former Whitman-Walker Health official and member of the D.C.-area HIV Planning Council, have expressed concern that patients’ ability to refill their ADAP prescriptions could be jeopardized if too few pharmacies agree to be part of the new DOH pharmacy network.

Kim said Grubbs planned to stop serving ADAP patients beginning July 1, when the new city-administered program was originally scheduled to go into effect. Kim couldn’t be immediately reached to determine whether Grubbs would continue filling ADAP prescriptions for another month following DOH’s decision to postpone the new program.

Kim indicated in an earlier interview that DOH might postpone implementation of the new program, but said DOH had not informed Care Pharmacies that it planned to do so.

He and others familiar with the ADAP program said they were told by the city that a list of the participating pharmacies in the new program would be released on June 15.

The city didn’t release such a list on that date, prompting pharmacists and activists to fear that too few pharmacies would join the new system to adequately serve ADAP patients in need of prescriptions.

Kim said Grubbs, which is believed to have processed the largest number of ADAP prescriptions in D.C. over the past decade, isn’t signing up for the city’s revamped program because the DOH has cut in half its reimbursement payment for ADAP drug prescriptions and plans to keep the lower payment in place for the next five years.

He said the lower payment makes it too costly for Grubb and other pharmacies to process ADAP prescriptions. He acknowledged that Care Pharmacies currently collects the reimbursement for the prescriptions from the city, takes a cut to cover its own administrative costs and disburses the remaining amount of about $7 per prescription to the other pharmacies in the current program. The city was expected to dispense the reimbursement directly to each pharmacy under the new system.

ADAP, a joint federal-state program, was created under the Ryan White AIDS Care Act in the early 1990s as a means of providing life-saving AIDS drugs to low-income patients as well as symptom-free people with HIV who don’t have private health insurance coverage and can’t afford to pay for the drugs.

Many of the HIV medications, such as anti-retroviral drugs, cost between $1,000 to as much as $2,000 for a one-month prescription, AIDS advocacy groups familiar with ADAP have said.

A staffer with the city’s AIDS administration, who isn’t authorized to speak to the media, said DOH chose to set up its own network of local pharmacies to process ADAP drug prescriptions rather than renew Care Pharmacies’ contract to “expand the options” for patients.

The staffer said DOH wanted to bring in more pharmacies and different types of pharmacies, including those providing mail order services, into the ADAP network beyond the 24 that have been participating under the Care Pharmacies network.

Kim, who serves on the Care Pharmacies board of directors, said that in addition to about 24 pharmacies that are part of the Care Pharmacies franchise, several unaffiliated pharmacies were part of Care’s ADAP network. Among them was Whitman-Walker Health, the city’s largest private AIDS services provider, which has its own in-house pharmacy. Others included the AIDS Healthcare Foundation, a worldwide AIDS care provider that has an in-house pharmacy in its D.C. office; and Safeway supermarket stores, which also have in-house pharmacies.

Foreman said the non-profit group CMS Health Initiative, with which she is affiliated, has provided quality control training and supervision under a city contract to ensure that D.C. pharmacies dispensing ADAP drugs meet the city’s requirements under the ADAP program operated by Care Pharmacies.

She said that in order to be approved by the city to dispense ADAP drugs, a pharmacy is required to provide patient counseling and a series of other patient-related services, including checks to make sure patients remain compliant with their drug regimen and don’t drop out of the program, placing their health at risk. She said all pharmacies in the program must provide free delivery service to patients.

Foreman and Kim also noted that under rules established by the D.C. DOH, pharmacies participating in the city’s ADAP program are reimbursed under a drug “replenishment” system. The system, which saved money for the city, requires the pharmacies to pay wholesale pharmaceutical supplies the first month’s prescription for all new patients. The city then replenishes the pharmacies with supplies of drugs for all subsequent prescriptions.

Kim said the system requires a pharmacy to pay out of pocket for the first prescription, which could come to between $1,000 and $2,000. He said he now fears that the expected fewer number of pharmacies that join the city’s in-house network will be hit by dozens of patients dropped from the pharmacies like Grubb’s, that choose not to join the new network.

“They could be facing an initial payment of $40,000 in a single month,” Kim said. “Many of them just can’t absorb that. They are small, independent pharmacies.”

One city government source, speaking on condition of anonymity, said Care Pharmacy and its representatives were exaggerating the potential harm the changes will have on patients because the city has ended what the source called a “sweetheart deal” for Care Pharmacies.

Kim disputes claims by sources from the DOH that the new city-operated network will include improved services and options over and above the Care Pharmacies contract.

“Basically, in my opinion, it’s all about money,” he said. “They feel that they are paying too much for the ADAP program. If you look at their program, they just took the current program that’s being run by Care Pharmacies and then they put it out and stamped it with their name and they cut the reimbursement in half. And that’s it,” he said.

“So if they say they’ve improved the program somewhat that’s a flat out lie because they haven’t done anything to the program except cut the reimbursement in half.

He said the current per-prescription reimbursement to Care Pharmacies is $20.50. DOH has invited pharmacies to apply to be accepted into the new program for a reimbursement of $10.50, he said.

“I can tell you that $10.50 was the rate that was given to us about 10 years ago,” Kim said. “It just doesn’t cover the costs.”

Whitman-Walker and AIDS Healthcare Foundation are among the local pharmacy providers that have signed up to be part of the new city ADAP network, representatives of the two organizations said.

Jerame Zelner, regional director of AIDS Healthcare Foundation’s pharmacies, said AHF is “very concerned” that many ADAP patients in D.C. will be unable to refill their prescriptions if a large number of local pharmacies that once participated in the program don’t join the new city network.

“We are taking steps to step in and help,” he said, noting that AHF, with a multi-million dollar budget, has the financial cushion to absorb the cost of a first month’s supply of drugs that other smaller pharmacies may not have.

AIDS Healthcare Foundation’s offices and pharmacy are located at 2141 K St., N.W., Suite 606. Zelner said that AHA, like all pharmacies participating in the current and soon-to-be started ADAP pharmacy network, provides fill delivery services for prescription drugs.

Hawkins of the HIV Planning Council said the Council is also concerned about patients not being able to fill prescriptions during the transition into the new program.

“No one from the city has told us how many pharmacies are dropping out and how many will be joining the new system,” she said. She said the Planning Council would be taking up the issue at an executive committee meeting on June 21.

Don Blanchon, Whitman-Walker’s executive director, said he doesn’t believe patients will suffer under the new system and said Whitman-Walker looks forward to its participation in the new program.

According to Blanchon, a decision during the past few years by the city to transfer many of its ADAP patients to the city’s Medicaid program has significantly decreased the number of remaining ADAP patients.

“There are currently around 500 ADAP patients and Whitman-Walker has 400 of them,” he said.

He said he doesn’t think city pharmacies should have a problem dispensing prescription drugs to the remaining 100.

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Monkeypox

US contributes more than $90 million to fight mpox outbreak in Africa

WHO and Africa CDC has declared a public health emergency

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The U.S. has contributed more than $90 million to the fight against the mpox outbreak in Africa. (Photo courtesy of the Centers for Disease Control and Prevention)

The U.S. has contributed more than $90 million to the fight against the mpox outbreak in Africa.

The U.S. Agency for International Development on Tuesday in a press release announced “up to an additional” $35 million “in emergency health assistance to bolster response efforts for the clade I mpox outbreak in Central and Eastern Africa, pending congressional notification.” The press release notes the Biden-Harris administration previously pledged more than $55 million to fight the outbreak in Congo and other African countries.

“The additional assistance announced today will enable USAID to continue working closely with affected countries, as well as regional and global health partners, to expand support and reduce the impact of this outbreak as it continues to evolve,” it reads. “USAID support includes assistance with surveillance, diagnostics, risk communication and community engagement, infection prevention and control, case management, and vaccination planning and coordination.” 

The World Health Organization and the Africa Centers for Disease Control and Prevention last week declared the outbreak a public health emergency.

The Washington Blade last week reported there are more than 17,000 suspected mpox cases across in Congo, Uganda, Kenya, Rwanda, and other African countries. The outbreak has claimed more than 500 lives, mostly in Congo. 

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Mpox outbreak in Africa declared global health emergency

ONE: 10 million vaccine doses needed on the continent

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The declaration of a public health emergency over an mpox outbreak in Africa has prompted calls for additional vaccine doses for the continent. (Photo courtesy of the Centers for Disease Control and Prevention)

Medical facilities that provide treatment to gay and bisexual men in some East African countries are already collaborating with them to prevent the spread of a new wave of mpox cases after the World Health Organization on Wednesday declared a global health emergency.

The collaboration, both in Uganda and Kenya, comes amid WHO’s latest report released on Aug. 12, which reveals that nine out of every 10 reported mpox cases are men with sex as the most common cause of infection. 

The global mpox outbreak report — based on data that national authorities collected between January 2022 and June of this year — notes 87,189 of the 90,410 reported cases were men. Ninety-six percent of whom were infected through sex.

Sexual contact as the leading mode of transmission accounted for 19,102 of 22,802 cases, followed by non-sexual person-to-person contact. Genital rash was the most common symptom, followed by fever and systemic rash.

The WHO report states the pattern of mpox virus transmission has persisted over the last six months, with 97 percent of new cases reporting sexual contact through oral, vaginal, or anal sex with infected people. 

“Sexual transmission has been recorded in the Democratic Republic of Congo among sex workers and men who have sex with men,” the report reads. “Among cases exposed through sexual contact in the Democratic Republic of the Congo, some individuals present only with genital lesions, rather than the more typical extensive rash associated with the virus.”

The growing mpox cases, which are now more than 2,800 reported cases in at least 13 African countries that include Kenya, Uganda, Rwanda, and prompted the Africa Centers for Disease Control and Prevention this week to declare the disease a public health emergency for resource mobilization on the continent to tackle it.

“Africa has long been on the frontlines in the fight against infectious diseases, often with limited resources,” said Africa CDC Director General Jean Kaseya. “The battle against Mpox demands a global response. We need your support, expertise, and solidarity. The world cannot afford to turn a blind eye to this crisis.” 

The disease has so far claimed more than 500 lives, mostly in Congo, even as the Africa CDC notes suspected mpox cases across the continent have surged past 17,000, compared to 7,146 cases in 2022 and 14,957 cases last year.   

“This is just the tip of the iceberg when we consider the many weaknesses in surveillance, laboratory testing, and contact tracing,” Kaseya said.  

WHO, led by Director General Tedros Adhanom Ghebreyesus, also followed the Africa CDC’s move by declaring the mpox outbreak a public health emergency of international concern.

The latest WHO report reveals that men, including those who identify as gay and bisexual, constitute most mpox cases in Kenya and Uganda. The two countries have recorded their first cases, and has put queer rights organizations and health care centers that treat the LGBTQ community on high alert. 

The Uganda Minority Shelters Consortium, for example, confirmed to the Washington Blade that the collaboration with health service providers to prevent the spread of mpox among gay and bisexual men is “nascent and uneven.” 

“While some community-led health service providers such as Ark Wellness Clinic, Children of the Sun Clinic, Ice Breakers Uganda Clinic, and Happy Family Youth Clinic, have demonstrated commendable efforts, widespread collaboration on mpox prevention remains a significant gap,” UMSC Coordinator John Grace stated. “This is particularly evident when compared to the response to the previous Red Eyes outbreak within the LGBT community.”

Grace noted that as of Wednesday, there were no known queer-friendly health service providers to offer mpox vaccinations to men who have sex with men. He called for health care centers to provide inclusive services and a more coordinated approach.

Although Grace pointed out the fear of discrimination — and particularly Uganda’s Anti-Homosexuality Act — remains a big barrier to mpox prevention through testing, vaccination, and treatment among queer people, he confirmed no mpox cases have been reported among the LGBTQ community.

Uganda so far has reported two mpox cases — refugees who had travelled from Congo.

“We are for the most part encouraging safer sex practices even after potential future vaccinations are conducted as it can also be spread through bodily fluids like saliva and sweat,” Grace said. 

Grace also noted that raising awareness about mpox among the queer community and seeking treatment when infected remains a challenge due to the historical and ongoing homophobic stigma and that more comprehensive and reliable advocacy is needed. He said Grindr and other digital platforms have been crucial in raising awareness.

The declarations of mpox as a global health emergency have already attracted demand for global leaders to support African countries to swiftly obtain the necessary vaccines and diagnostics.

“History shows we must act quickly and decisively when a public health emergency strikes. The current Mpox outbreak in Africa is one such emergency,” said ONE Global Health Senior Policy Director Jenny Ottenhoff.

ONE is a global, nonpartisan organization that advocates for the investments needed to create economic opportunities and healthier lives in Africa.

Ottenhoff warned failure to support the African countries with medical supplies needed to tackle mpox would leave the continent defenseless against the virus.  

To ensure that African countries are adequately supported, ONE wants governments and pharmaceutical companies to urgently increase the provision of mpox vaccines so that the most affected African countries have affordable access to them. It also notes 10 million vaccine doses are currently needed to control the mpox outbreak in Africa, yet the continent has only 200,000 doses.

The Blade has reached out to Ishtar MSM, a community-based healthcare center in Nairobi, Kenya, that offers to service to gay and bisexual men, about their response to the mpox outbreak. 

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White House urged to expand PrEP coverage for injectable form

HIV/AIDS service organizations made call on Wednesday

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Apretude is a long-lasting PrEP injection that has proven to be significantly more effective at reducing the risk of sexually-acquired HIV. (Photo courtesy of ViiV Healthcare)

A coalition of 63 organizations dedicated to ending HIV called on the Biden-Harris administration on Wednesday to require insurers to cover long-acting pre-exposure prophylaxis (PrEP) without cost-sharing.

In a letter to Chiquita Brooks-LaSure, administrator of the Centers for Medicare and Medicaid Services, the groups emphasized the need for broad and equitable access to PrEP free of insurance barriers.

Long-acting PrEP is an injectable form of PrEP that’s effective over a long period of time. The FDA approved Apretude (cabotegravir extended-release injectable suspension) as the first and only long-acting injectable PrEP in late 2021. It’s intended for adults and adolescents weighing at least 77 lbs. who are at risk for HIV through sex.

The U.S. Preventive Services Task Force updated its recommendation for PrEP on Aug. 22, 2023, to include new medications such as the first long-acting PrEP drug. The coalition wants CMS to issue guidance requiring insurers to cover all forms of PrEP, including current and future FDA-approved drugs.

“Long-acting PrEP can be the answer to low PrEP uptake, particularly in communities not using PrEP today,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “The Biden administration has an opportunity to ensure that people with private insurance can access PrEP now and into the future, free of any cost-sharing, with properly worded guidance to insurers.”

Currently, only 36 percent of those who could benefit from PrEP are using it. Significant disparities exist among racial and ethnic groups. Black people constitute 39 percent of new HIV diagnoses but only 14 percent of PrEP users, while Latinos represent 31 percent of new diagnoses but only 18 percent of PrEP users. In contrast, white people represent 24 percent of HIV diagnoses but 64 percent of PrEP users.

The groups also want CMS to prohibit insurers from employing prior authorization for PrEP, citing it as a significant barrier to access. Several states, including New York and California, already prohibit prior authorization for PrEP.

Modeling conducted for HIV+Hep, based on clinical trials of a once every 2-month injection, suggests that 87 percent more HIV cases would be averted compared to daily oral PrEP, with $4.25 billion in averted healthcare costs over 10 years.

Despite guidance issued to insurers in July 2021, PrEP users continue to report being charged cost-sharing for both the drug and ancillary services. A recent review of claims data found that 36 percent of PrEP users were charged for their drugs, and even 31 percent of those using generic PrEP faced cost-sharing.

The coalition’s letter follows a more detailed communication sent by HIV+Hepatitis Policy Institute to the Biden administration on July 2.

Signatories to the community letter include Advocates for Youth, AIDS United, Equality California, Fenway Health, Human Rights Campaign, and the National Coalition of STD Directors, among others.

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