Zakieh Abuelkhair, RPH, MPBA Candidate

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.

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

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.”

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.

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.

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.

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. 

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.

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.

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.

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.

 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.

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.

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Axios International. (2021). Retrieved from https://axiosint.com/

Medication Adherence. (2021). Retrieved 16 April 2021, from https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.108.768986

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Articles

The 5 largest specialty therapeutic groups—oncology, autoimmune, immunology, HIV, and multiple sclerosis—will account for 74% of specialty spending growth over the next five years.

Establishing Specialty Pharmacy Beyond US Borders: Opportunities and Challenges

Internships can play a huge role in your future career plans. I remember I had the opportunity of joining one of the hospitals in the United Arab Emirates. As a pharmacy intern, I was checking in with patients to meet their needs.

During this time, I was approached by a patient in his mid 70s who was asking for his specialty medication refill. I tried to look up his medical record to check whether his medications were due for refill.

After the patient had waited for 30 minutes in line, I had to inform him that he must wait another 48-72 hours to obtain a prior authorization (PA) from the insurance company to approve his specialty medication, and only then could we dispense it to him.

The patient was disappointed, he said that he is already in pain and has to take his medication today. I could not handle seeing the patient in distress and really wanted to assist him by expediting the PA process, so he can take his medicine on time. I went back and forth with the insurance specialists, who told me there was nothing we can do and that the patient will have to wait.

At that point, it did not make sense to me that patients who have highly complex diseases wait in the same line as patients who have a cough/cold, acne or with a simple medical condition. It also frustrated me that no one proactively called the patient to remind him that he has a refill for his specialty medication.

This incident was my first encounter with specialty medications. I did not realize there were pharmacies who fully specialize and focus on patients with complex and rare diseases. The patient-centered specialty pharmacy model is intended to provide patients with complex diseases with a thorough and organized model of treatment, deliver improved clinical and economic outcomes, and accelerate accessibility to care for patients.

Specialty pharmacies manage the patient’s specialty medications from A to Z. Providing services of managing medication adherence; education on how to use the medication since many specialty drugs are infusion or injectable forms; proper handling and administration of the drug; careful control of drug dosing and adverse effects; 24-hour access to pharmacists; PA and financial assistance; shipping coordination; reaching the patient proactively for prescription refill and renewal; and patient monitoring for safety and efficacy.

Specialty pharmacy is currently found in the United States and in Canada, but nowhere else in the world, yet. I intentionally say “yet” because I am an optimist who hopes to expand specialty pharmacy beyond North America in the near future.

Specialty pharmacy is one of the fastest growing industries in the United States. To serve this blooming industry, National Association of Specialty Pharmacy was founded in 2012. Specialty drugs were expected to account for 50% of US drug spending in year 2020.

 Dr. Scott Knoer, former chief pharmacy officer at Cleveland Clinic Ohio and current CEO of the American Pharmacist Association, believes it is a worthwhile business and advises other health systems to get into the specialty pharmacy business.

Reasons to invest in a specialty pharmacy include better patient and provider experience, improved patient health outcomes, enhanced continuum of care, improved supply chain efficiency, and capture incremental revenue and margin. In one of the conferences held by Cleveland Clinic, UAE, Knoer mentions “specialty pharmacy is the new disruption.”

I wanted to be part of this disruption and believe patients with highly complex diseases deserve the attention that they need and us, as pharmacists, are capable of providing it to them. We have capabilities beyond just dispensing and counseling and can add value and optimize health outcomes.

Looking back, I cannot imagine that it only took one patient interaction to lead me nicely to where I am today. Reflecting on my internship experience is a key factor for learning about specialty pharmacy. I continued to do my research on this topic and decided I wanted to specialize in this field.

However, I knew if I wanted to enter this arena, I first need to gain practical/academic knowledge to get the needed expertise to implement specialty pharmacy in our region. My reflection process was best led by my two mentors after I finished my internship. My mentors encouraged me to pursue a master’s degree in Pharmacy Business Administration with a focus track in specialty pharmacy at the University of Pittsburgh.

I cannot recommend enough the importance of having a mentor. Their guidance and advice helped me to take on education/career opportunities that otherwise I would not have. I had no clarity in my career path but having visionary leaders as mentors pushed me to find that missing vision and reach my goals.

If you are a current pharmacy intern or a fresh pharmacy graduate, try to take the opportunity in such situations. Apply for internships. Get involved. Try different fields to see what you like and see where you fit in.

You must take hold of what you want your next five years to look like. Communicate with pioneers in the field of pharmacy and network because it could be your chance to get yourself internship/work opportunities. Attend conferences because it will add a different perspective from what you just learned in pharmacy school.

I remember post-graduation, many pharmacy graduates were lost because we had no guidance. One of my previous managers had advised me to experiment as much as I can while I still have the chance. Experimenting could be in hospital pharmacies, retail pharmacies, pharmaceutical companies, pharmaceutical manufacturers, patient access organizations, insurance companies, and many more.

Different experiences in different fields will help you understand your “why” and enable you to be more deeply committed to pursuing your goals. One of the many quotes I like is by Simon Sinek, who said “People don’t buy what you do, they buy why you do it.”

You will have a hard time persuading people to embrace the profession and efforts to enhance patient care without understanding your "why." During this critical period for pharmacy, it is time to use this power to continue driving the profession forward.

Pharmacy is a growing and evolving field and over the next 10 years, I believe pharmacy will not look the same as it does today. Pharmacists will have to offer personalized care to their patients, with the advancement in pharmacogenomics, personalized medicine, and 3D printed compounded medication.

In addition to digital therapeutics, electroceuticals and other medical devices will treat common medical conditions. Pharmacists must adapt and find their space before it is filled by others. They must define their roles and enhance their expertise by gaining new skills or knowledge in these areas of growing business potential.

Pharmacists made a great impact in the United States and Canada for the vaccination program and now we see the fruit in the pandemic and with public health issues. Pharmacists need to build on this momentum of patient trust and move into more visible roles for virtual reality, telemedicine, and advanced biotherapeutics.

Vast opportunities are opening every day for pharmacists, especially with the upcoming complex biological products that need a lot of therapeutic drug monitoring and fine adjustment of doses.

, earned her bachelor’s degree of Pharmacy from the University of Sharjah in the UAE and is currently enrolled in the 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.

Specialty pharmacy: A unique and growing industry. (2013). Retrieved 21 February 2021, from https://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry

https:// (2016). Retrieved 21 February 2021, from https://naspnet.org/wp-content/uploads/2017/02/NASP-Defintions-final-2.16.pdf

Hospitals launch specialty pharmacies to curb drug costs. (2013). Retrieved 21 February 2021, from https://www.modernhealthcare.com/article/20151212/MAGAZINE/312129963/hospitals-launch-specialty-pharmacies-to-curb-drug-costs

Vast opportunities are opening every day for pharmacists, especially with the upcoming complex biological products that need a lot of therapeutic drug monitoring and fine adjustment of doses. 