Establishing Specialty Pharmacy Beyond US Borders: Opportunities and Challenges

The United States, the European Union (EU), and Canada are currently the world leaders in specialty pharmacy. IQVIA’s global use of medicine report states that by 2023, developed markets will see a growth in specialty spending from $336 billion in 2018 to nearly $505 billion and the specialty share of total pharmaceutical spending will reach 50%, since the majority of new drugs have been and will continue to be in specialty groups.

According to IQVIA’s 2018 market prognosis report, 10 developed markets including the United States, EU (UK, Germany, Italy, France and Spain), and other major developed countries (Japan, Canada, Australia, and South Korea) account for 66% of global spending. Specialty share of spending across these countries grew from 42% in 2018 to 50% in 2023.

The 5 largest specialty therapeutic groups will drive the majority of growth: oncology, autoimmune, immunology, HIV, and multiple sclerosis. Over the 5 years, these groups will contribute 74% to specialty growth.¹

The question is: “Do we expect to see specialty pharmacy expanding beyond these regions”?

UAE’s Definition of Specialty Drugs

As specialty drugs do not have a universal definition yet, United Arab Emirates (UAE) has its own definition for what a specialty drug is. Daman, the largest health insurer in Abu Dhabi and third largest in Dubai, defines specialty medications as “drugs used to treat chronic health conditions where they are continuously monitored and are subject to special evaluation requiring full medical documentation for authorization.”²

Hence, they created a list to ensure that those medications are prescribed to the right population. Daman emphasized that the turnaround time for approving specialty drugs might take longer than normal. Daman’s specialty drugs list in 2019 included 37 medications, which increased to 57 in 2021.³

As you can see, the number of specialty drugs has been on the rise, which shows the huge interest the UAE has in making these specialty medications available for patients in need.

The overall orphan disease prevalence in the MENA region is 2.97 million patients. According to a white paper published by IQVIA in 2018, it is estimated that 50,000 patients out of the 9.16 million total population are diagnosed with an orphan disease in the UAE.⁴

The Ministry of Health and Prevention in the United Arab Emirates (MOHAP) is committed to increasing patient access to treatments by prioritizing the delivery, assessment, and registration of breakthrough and orphan medications.

Fast Track Registration of Specialty Drugs

UAE drug authorities have been putting lots of efforts into fast-tracking registration for innovative products directly after FDA or EMA approval. In 2018, MOHAP issued a Ministerial Decree for the Fast Track Registration of 1) drugs containing a, completely or partially new active ingredient and whose owner holds a patent (innovative drugs) and 2) drugs that are used for the treatment, diagnosis or prevention of rare diseases (orphan).

Even if final approval has not yet been granted by any of the relevant accredited international regulatory bodies, an innovative or orphan drug can be included in the Fast Track process following a favorable opinion issued by the regulatory bodies, as long as a certificate of pharmaceutical product is submitted to MOHAP once available.

As part of the process, the MOHAP Drug Registration Committee reviews an innovative drug or orphan drug application within 15 working days of submission, after which it will accept or reject the application within 10 working days the evaluation. Most of the members of the committee must vote in favor of approval.

The price is then decided after the committee has given its approval, and a certificate of registration and pricing for the medication will be issued.⁵

UAE’s Mandatory Health Insurance

In the past few years, UAE has increased its efforts in developing the health care sector in several ways. One of the ways was to introduce mandatory health insurance to all UAE nationals and expatriate residents and their families.

The implementation of compulsory health insurance in Abu Dhabi nearly a decade ago, and more recently in Dubai and Sharjah, has resulted in substantial growth in health insurance penetration. Authorities believe this mandate will help increase access to care and reduce costs concomitant with routine illnesses, check-ups, emergency treatments, and several other medical requirements.

Even with the insurance mandate in place, some specialty medications such as biologics can be quite expensive. Many patients have basic insurance with cap on annual spend on medications, while others are unable to afford co-payments for these types of medications.

Other medications are only covered for inpatients use but not for outpatient prescriptions such as oral oncology drugs. Therefore, a global pharmaceutical company launched a joint payment access program to improve access to these medications, and we can see many pharma companies following the same path too.

Specialty Hub Services Providers

To address this challenge, organizations such as Axios International and IQVIA were engaged back in 2016. Axios International had previously concentrated on uninsured patients until November 2015, when it started to expand its services to include covered patients who were having some challenges in paying their co-payments.

In addition to independently funded government patient assistance programs (PAP), Axios International and IQVIA are currently the only privately held organizations in the UAE offering PAPs. These programs are run together with the pharmaceutical companies to provide financial assistance to help patients access medications for little or no cost.

Clearly, not everyone qualifies, but many patients have been assisted. So, how do we know whether a patient qualifies? Axios uses its validated Patient Financial Eligibility Tool to evaluate a patient's ability to pay for treatment.⁶ The objective of this tool is to provide a complete picture of the patient’s income sources by taking 3 key metrics into account: income level, standard of living, and assets.

Specialty medications are usually classified as high-cost and high-complexity pharmaceuticals, which means it is not just a matter of cost. These drugs require specialized handling, administration, and storage due to their complex nature.

There are many other complexities associated with specialty drugs and patients are the ultimate victims of all these complexities. That is why such organizations not only provide financial assistance services but offer many services just like hub service providers in the United States, where they act as intermediaries between involved parties (patients, physicians, pharmacists, and pharmaceutical manufacturers). These services include claims support, prior authorization, patient education, adherence support services, drug administration, and home-based clinical support.

The above-mentioned patient services allow pharmaceutical manufacturers to positively affect the patient journey by ensuring efficient distribution of medication and improving adherence rate and outcomes. When patients are engaged, and followed up with during their treatment process, they will gain a greater understanding of their own journey, resulting in more favorable results.

Non-adherence is a growing concern; its consequences not only include health-related consequences (e.g., treatment failure, increased hospital admissions), but also financial ones.⁷ These hub service providers have taken a stand in this concern, committing to providing tailored communication to patients through both new and conventional methods—such as online web portals and telephone outreach—to promote medication adherence among patients.

Specialty Medications Providers and Availability

Many of the specialty medications require high-touch patient care management, which is why they are only available via limited distribution networks, such as hospitals or big pharmacy chains. For example, Luxturna, the first FDA-approved gene therapy for patients with inherited renal disease, can only be supplied to qualified centers/hospitals that meet certain criteria set by the European Medical Association (EMA).

These criteria might include the requirements of trained and competent physicians, as well as supply chain capability to transfer and store the medication, which requires a specific type of transportation (dry ice) and a specific type of freezer (-65 C). In addition, pharmacists must be trained and competent to handle, prepare, and deliver the medication in a ready-to-administer form, with the availability of the facility and equipment necessary for sterile preparation of the medication.

These requirements are not only limited to Luxturna, but to many of the specialty therapies available today. They typically require specialized handling to ensure the medication's quality and proper administration. This can demand complex handling, cold chain storage, and transportation in highly regulated environments, such as temperature-controlled areas, to ensure product integrity is maintained.

With the UAE becoming the third country to approve Luxturna, one of the most advanced gene therapies available worldwide, it demonstrates the country's commitment to bringing innovative and groundbreaking specialty medications to the market early on. The availability of this breakthrough medication was met with the enthusiastic support of the Ministry of Health, where the product’s registration took between 2 to 3 months.⁸

Conclusion

Specialty medications will account for nearly two-thirds of new product launches over the next 5 years, up from 61% in the previous 5 years.¹ With the increasing availability of specialty drugs, there must be a specialized space for better scrutiny and monitoring of these medications.

These complex, sensitive, and highly delicate therapies necessitate the formation of new distribution models to link patients to these costly therapies. Patients with complex and rare diseases receiving these therapies require more attention to ensure adherence to the therapy regimen and to effectively manage adverse effects.

There are currently no specialty pharmacies in the UAE that are fully dedicated in dispensing specialty medications with designated hub services. Presently, there are patient access organizations started in the country; however, they don’t offer the other services of specialty pharmacies, which is why there is a great opportunity to establish specialty pharmacy in the region.

Overcoming local regulations, insurance company acceptance, and pharmaceutical company support to the idea is imperative to the success of starting a specialty pharmacy in the UAE.

About the Author

Zakieh Abuelkhair earned her Bachelor Degree of Pharmacy from the University of Sharjah in the UAE and her Master of Pharmacy Business Administration (MPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. In the past 2 years, Zakieh has worked at Novartis Pharmaceuticals as a Disease Education Specialist and completed her 6-month pharmacy internship at Cleveland Clinic Abu Dhabi. Her current role is working as Pharmacy Operations Manager at Al Thiqa Specialty Pharmacy in an effort to transform the practice of Specialty Pharmacy in the Middle East.

References:

1. Retrieved 16 April 2021, from https://informatori.it/wp-content/uploads/2019/03/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf
2. Daman: Pharmaceutical benefits. (2021). Retrieved 16 April 2021, from https://www.damanhealth.ae/en/join-our-provider-network/pharmaceutical-benefits
3. Daman: Speciality Drug List. (2021). Retrieved 16 April 2021, from https://www.damanhealth.ae/en/join-our-provider-network/pharmaceutical-benefits/speciality-drug-list
4. Welcome to IQVIA - A New Path to Your Success Via Human Data Science. (2021). Retrieved 16 April 2021, from https://www.iqvia.com/
5. News - Ministry of Health and Prevention - UAE. (2021). Retrieved 16 April 2021, from https://www.mohap.gov.ae/en/MediaCenter/Pages/news.aspx
6. Axios International. (2021). Retrieved from https://axiosint.com/
7. Medication Adherence. (2021). Retrieved 16 April 2021, from https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.108.768986
8. (2021). Retrieved from https://cdn.sanity.io/files/0vv8moc6/pharmexec/2dfa2c99d13056cb33c19d76101e22b68077693e.pdf