Specialty medications can allow patients to go beyond managing symptoms to treat the root causes of diseases like never before.

Look no further than antiretroviral therapeutics (ARTs) to see the real-world impact of such medical innovation. These specialty medications have turned the tide in the war against HIV/AIDS. For ARTs to make the most difference, distribution models, retail and specialty pharmacies, must meet patients with HIV where they are to ensure widespread medication access and adherence.

BREAKTHROUGHS IN HIV TREATMENT
During the early days of the HIV/AIDS epidemic, providers had no available treatments to target the virus and were limited to interferon infusions to help manage disease symptoms at the cost of severe adverse effects.1,2 For 7 long years, patients and providers were powerless to stop the disease, until the first antiretroviral drug to treat HIV infections, azidothymidine, was FDA approved in 1987, providing the first glimmer of hope.1

Although far from a silver bullet, the development of azidothymidine sparked numerous breakthroughs in ART research. Today, providers can choose among 44 specialty medications to combat the rapidly mutating virus, and patients have the potential to live healthy lives, as long as they remain adherent to their prescribed ARTs (figure).3

Treatment has even advanced to the point where preemptive protection of people from HIV infection is possible through a powerful 2-drug (emtricitabine and tenofovir) preexposure prophylaxis (PrEP).4

CONSIDERATIONS FOR DRUG DISTRIBUTION
Benefits of Specialty Pharmacies
Although specialty medications can offer patients distinct clinical benefits, it is no secret that they can be difficult to access, adhere to, and afford.5-8 Their significant complexity and expense often demand additional safety measure, close clinical monitoring, and tighter control of utilization, relative to traditional medications.8

In fact, specialty pharmacies emerged in the early 1990s to help manage administrative and operational challenges that mostly commonly occur in niche therapeutic areas, such as HIV.9 These pharmacies offer high-touch services and are typically staffed with team members trained in specific therapeutics areas.

For example, Equitas Health, a regional specialty pharmacy based in Columbus, Ohio, ensures that all pharmacists are certified by the American Academy of HIV Medicine to deliver expert care to patients with HIV.

“This level of expertise, combined with consultation for every new patient, enables our pharmacists to verify prescription history and start patients on the right medications as soon as possible,” according to Nick Saltsman, PharmD, RPh, AAHIVP, director of pharmacy at Equitas Health.

Specialty pharmacies provide high-touch access and reimbursement services that include clinical counseling, financial and prior authorization support, medication dispensing, patient eligibility and benefits investigation, and risk evaluation and mitigation strategy requirements to patients.10

Specialty pharmacies are also equipped to handle the common cold-chain distribution requirements of specialty medications.11 Although dispensing to patients most often occurs through the mail, pickup can be available via brick-and-mortar specialty pharmacy locations. However, relative to retail pharmacies, this channel can be practically limited, as regional specialty pharmacies may not be close to patients.

Benefits of Retail Pharmacies
Although certain specialty medications can be dispensed through retail pharmacies, this distribution channel is not as widely used for most specialty therapies.12

Many pharmaceutical manufacturers control distribution of specialty medications through limited distribution networks,8 which often do not include retail pharmacies. Retail pharmacy staff members can also lack specialized training in specific therapeutic areas, which can be important for counseling patients about their prescriptions or flagging potentially dangerous drug-drug interactions.12 However, it should be noted that patients with high health literacy or more disease experience may not need such support.

As retail pharmacies typically handle a larger volume of patients seeking to pick up traditional medications each day, dealing with the added and complex workload of specialty medications can be burdensome to staff members. In addition, these stores may not be equipped to stock cold-chain drugs or handle complicated workflows, such as risk evaluation and mitigation strategy.12

On the other hand, many patients feel most comfortable picking up medications at their local retail pharmacies.13 These patients may have a positive relationship with their local pharmacists and trust their counsel pertaining to prescribed specialty medications. Some patients may also worry about missing delivery of their specialty medication when traveling out of town and instead seek the convenience of pickup at 1 of 67,000 retail pharmacies nationwide.14 To help fill the care gaps that exist for retail pharmacies, it is possible in some instances for patients to choose where they would like to pick up their medications, while still receiving high-touch support from a specialty pharmacy care team.12,15 In this model, regardless of how or where patients choose to receive their medications, they will each experience an added layer of care.12,15 For patients with HIV, these considerations for distribution via retail or specialty pharmacies can be more specific and have a more influential effect on medication access and adherence.

UNIQUE DISTRIBUTION CONSIDERATIONS FOR HIV
Privacy
For patients with HIV, economic, logistical, and social factors can affect access and adherence to specialty therapies. For example, social stigma surrounding HIV can negatively influence infected patients’ career trajectories and employment opportunities.16

As a result, maintaining anonymity is a primary concern for many patients with HIV. In fact, privacy concerns have been a central issue, among several others, in past litigation involving mandatory mail delivery of ARTs to patients with HIV.17,18 These patients may also prefer to pick up their specialty medications during off-peak pharmacy hours to protect their privacy, which may be better enabled through the retail pharmacy setting.

Beyond such concerns for patients with HIV, the US Department of Health and Human Services reports that only a fraction of the at-risk population is benefiting from PrEP, leaving those most at risk for HIV infection without proper protection.19

For these reasons, it is important that patients with HIV and those at risk for infection are able to receive their ARTs or PrEP in a way that makes them feel comfortable. As nearly all ARTs and PrEP are orally administered in capsule or tablet form, with just 1 administered by injection,20 complicated cold-chain distribution and unique administration methods (eg, infusion and nebulization) should not be a limitation for approving patients’ preferred dispensing method.

Progress in widespread distribution of PrEP was made last year when large chain retail pharmacies began making the medication freely available to at-risk people through the government-funded “Ready, Set, PrEP” program.21

Cost
With monthly costs of about $300 to $4100 per patient or $3600 to $49,200 per year, ARTs can be difficult to afford for most patients with HIV.22 Ensuring that these patients are connected with financial resources must be a primary concern for distributing pharmacies, whether retail or specialty.

Adherence
As patients with HIV can take multiple medications each day to control the disease, adherence can be challenging.23,24 Reducing barriers to medication access and understanding why patients struggle to take their medications can have a positive effect on their adherence. Although it has been reported that support through specialty pharmacies can improve adherence metrics for patients with HIV,25 others suggest that retail pharmacies can increase patient adherence, as well.13 It is likely that adherence as a function of the retail or specialty pharmacy setting varies on a per-patient basis.

To ensure efficient and quick access to ARTs, drug distribution channels must help patients overcome as many HIV-specific challenges as possible. As these often vary on an individual basis, maintaining distribution through both retail and specialty pharmacies can help reach the most patients with HIV, while also providing an appropriate level of support based on personal circumstances.
 
Erica Conroy, PhD, is vice president of specialty, and Kyle Grimslid, PharmD, RPh, is market development director, both at CoverMyMeds in Columbus, Ohio.


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