Dr. Mahmoud Abdelaal
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Market access, reimbursement and payer evidence

Market access, from the clinical evidence to the patient in treatment

I am a physician and medical affairs manager who has taken therapies from the first diagnosis in a market to national approval and government coverage. I have prepared therapy dossiers, taken part in reimbursement discussions with ministries of health and built the patient identification that any value story depends on, across six Gulf markets. This page is the access side of that work.

6 Gulf markets. 20+ orphan and speciality products. 300+ patients in treatment within twelve months. 18 partner companies.

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Abstract illustration of evidence and data review

300+

patients in treatment within twelve months

6 months

from first diagnosis to national approval, Oman

20+

orphan and speciality products

6

Gulf markets covered

In short

Who you are working with

I am Mahmoud A. Z. Abdelaal, MBBCh, PGD, a physician by training and a medical affairs manager by practice. Market access in my work is not a slide about pricing. It is the medical case that has to survive contact with a health authority: who the patients are, how many of them are actually diagnosed, what the therapy changes for them, and what the treating physician will say when the ministry asks.

That work sat inside my medical affairs remit rather than beside it. I held the regional medical plan for a rare disease and gene therapy portfolio across the United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Bahrain and Oman, as the medical counterpart to the regional distribution partners, covering more than twenty orphan and speciality products. I prepared therapy dossiers, took part in reimbursement discussions with Gulf ministries of health, ran a monthly cross functional forum with commercial, regulatory and access colleagues, and trained the physicians whose patients the access case was about. I also work at Cleveland Clinic Abu Dhabi as a medical interpreter and patient communication specialist, which keeps me next to the Arabic speaking patients at the centre of these arguments.

I am clear about the boundary. I am not a pricing or health economics specialist and I do not present myself as one. What I bring is the clinical and evidence side of access: the diagnosis route, the patient numbers, the burden of disease, the real-world data plan, and the ability to stand in front of a payer or a ministry committee and answer the clinical questions without overstating what the data shows.

Capabilities

What I do on the access side, and what it is built on

Each of these is work I have done inside a medical affairs remit, with the record behind it.

Patient identification and the diagnostic route

The first access problem is usually diagnostic rather than financial. I map how patients are found in a market, work with diagnostic laboratories to broaden next-generation sequencing access, and build identification pathways that shorten the time from first symptom to confirmed diagnosis. In the cystic fibrosis portfolio that made a mutation-specific therapy reachable at all, and the same logic runs through Duchenne muscular dystrophy and every therapy whose eligibility depends on a genotype.

300+ cystic fibrosis patients in treatment within twelve months

Therapy dossiers and the evidence case

I prepare the medical case a health authority reads: the disease and its burden, the patient population and how it was estimated, the unmet need, the clinical evidence and its limits, and the place of the therapy in the treatment pathway. In the Gulf these went in as therapy dossiers to ministries of health, supported by one page summaries and position papers that kept global and local teams on one version of the evidence.

Therapy dossiers prepared for Gulf ministries of health

Reimbursement discussions with health authorities

The conversation itself, from the medical seat. I have taken part in reimbursement discussions with ministries of health in the Gulf, prepared the clinical material behind them, and trained the physicians who speak to the same evidence locally. My role in those rooms is to answer the clinical questions accurately, including the ones where the honest answer is that the data does not yet show it.

Government coverage secured for eligible cystic fibrosis patients

Health technology assessment and payer facing evidence

Formal health technology assessment and payer review ask for the comparator, the subgroup, the uncertainty and the budget impact alongside the headline result. I build the clinical half of that answer, and I have built it in health systems where no formal assessment body exists and the same questions arrive from a ministry or a national treatment programme instead. The standard of proof is the same; only the paperwork changes.

Clinical and payer facing case built for two national programmes

Managed entry and coverage with conditions

Coverage granted with conditions attached, whether that is a population limit, a price arrangement, a review point or a commitment to collect data and revisit the decision. In the Gulf it takes the shape of government agreements to cover treatment costs for eligible patients. I work the medical side of that: who is eligible, how eligibility is confirmed, and what has to be measured afterwards to keep the arrangement standing.

Government agreements covering treatment costs for eligible patients

Real-world data, registries and follow-up

Coverage decisions in rare disease lean on evidence that trials cannot produce, which is why the data plan has to start before launch. I set up a post-launch registry for an ultra rare therapy so treated patients could be followed over time, worked on Gulf real-world evidence in sickle cell disease with haematology specialists, and completed the CITI Program research ethics and good clinical practice curriculum, one hundred and eighteen modules in total.

Post-launch registry set up for an ultra rare therapy

Patient access, information and patient groups

Access is also whether a patient and their family can act on the therapy once it exists. I have translated patient information material, supported patient groups, and run an awareness campaign with a patient advocate who had a public following, all of which move diagnosis earlier in the pathway. In an ultra rare condition where three patients were on treatment within three months of launch, that work is the difference between a therapy existing and a patient receiving it.

3 congenital leptin deficiency patients treated within 3 months of launch

Tell me about the market and the decision point

Method

How access work runs, and where it usually fails

Six stages, in the order that matters. Most access cases that fail start at the first one.

  1. 01

    Start with the patient pathway

    Before any evidence is assembled, I trace how a patient is found: which specialty sees them first, which test confirms the diagnosis, where the journey stalls and how long the whole thing takes. In Oman the IQVIA data showed zero recognised cases of acute hepatic porphyria, so the pathway had to be built from field visits and physician conversations. That is how an endocrinologist with a multi-generational family under his care came to test for a disease that was not on his list.

  2. 02

    Count the patients and show your working

    An access case lives or dies on the denominator. I work from diagnosis rates rather than prevalence alone, because in a Gulf market the diagnosed population is often a fraction of the real one. For a mutation-specific therapy the eligible number is smaller still, and I would rather present a smaller figure a ministry can verify than a large one it will question.

  3. 03

    Build the evidence story around the decision

    A health technology assessment or a payer review asks the same handful of questions: what is the unmet need, what does the therapy change, how certain is the evidence, and what happens to the budget. I assemble the clinical answer from the trial data, the disease burden and the treating network, and where the evidence is thin I say so and set out what would close the gap.

  4. 04

    Prepare the dossier and the clinical voice

    Therapy dossiers, patient population analyses, one page summaries and position papers that go back to global medical teams. I have prepared dossiers and taken part in reimbursement discussions with ministries of health in the Gulf, and I have supported the clinicians who present the case themselves, because a treating physician describing the patient in front of them carries further than any slide.

  5. 05

    Make the diagnosis reachable

    Access without diagnosis is a fiction. I have worked with diagnostic laboratories to broaden next-generation sequencing access, built patient identification pathways to cut diagnostic delay, translated patient information and supported patient groups. In cystic fibrosis that work put more than three hundred patients into treatment within twelve months of the coverage agreements, and the same diagnostic partnership model was later reused in a Duchenne muscular dystrophy assessment.

  6. 06

    Stay after the decision and prove the value

    Coverage is a starting point, not an ending. Post-launch registries, real-world data, follow-up of treated patients and honest reporting back to the authority are what keep a therapy available. I set up a post-launch registry for an ultra rare therapy at launch so treated patients could be followed over time, and I have worked on Gulf real-world evidence that went into scientific exchange with haematologists.

Markets

Where I work, and what access looks like in each market

Abstract illustration of the six Gulf markets covered

Gulf: United Arab Emirates, Saudi Arabia, Qatar, Kuwait, Bahrain and Oman

In the Gulf the payer is usually the state, and the route runs through a ministry of health, a national treatment programme or a government agreement covering the cost of treatment for eligible patients. There is no single template across six countries: each health authority reviews in its own way, while the physician community is shared across all of them. That is the environment my access record comes from, including the cystic fibrosis programme that reached government coverage and the porphyria work that went from zero recognised cases to national approval in six months.

Italy

Italy sets reimbursement at national level and applies it regionally, with registries built into how a therapy is used and monitored, and rare disease and gene therapy have real centres of gravity in Milan, Rome and Lombardy. Medical Affairs is used untranslated there and the field medical role is the informatore scientifico. I hold work rights in Italy, I am learning Italian at A1 through intensive courses, and I am open to Italy based roles as the language develops.

France

France runs a national assessment and then a separate price negotiation, with the patient pathway and the evidence requirements written down in some detail. I hold work rights in France, my English is C1 with Arabic as a native language, and I work with French language material as part of my regulatory and scientific reading. I am open to France based roles and to above country roles that work in English.

Questions

Questions I am actually asked about access

The access questions recruiters, agencies and companies tend to ask, answered without inflation.

What does market access mean in pharma, and where does medical affairs fit?

Market access is everything between a therapy being approved and a patient actually receiving it: the reimbursement decision, the price arrangement, the listing, the treatment programme and the pathway that brings the patient to the therapy. Medical affairs sits on the evidence side of that, supplying the patient numbers, the diagnosis route, the clinical argument, the real-world data plan and the training. I have done that work as the medical function inside a partner organisation rather than as a payer consultant.

Have you ever actually secured reimbursement?

In the Gulf, yes. I supported the programme that secured government coverage for eligible cystic fibrosis patients and led to more than three hundred patients in treatment within twelve months, prepared therapy dossiers and took part in reimbursement discussions with ministries of health, and worked the acute hepatic porphyria programme that reached national approval in Oman within six months of the country's first official diagnosis. I have not run an Italian or a French reimbursement process, and I do not claim to have.

What is a value dossier, and what goes into one?

The written case for a therapy: the disease and its burden, the patient population and how it was estimated, the unmet need, the clinical evidence and its limits, the place in treatment, and the data that will show what happens in practice after coverage. I prepared therapy dossiers for Gulf health authorities. The discipline is the same in every market: every number traceable to a source, and no claim the data cannot carry.

How does health technology assessment change what medical affairs has to produce?

It raises the standard of proof and it moves the questions earlier. Health technology assessment style review asks for the comparator, the subgroup, the uncertainty and the budget impact, not only the headline result. Medical affairs answers the clinical part of that, and has to be able to say where the evidence is thin, because an overstatement found in review costs more than an acknowledged gap. In markets without a formal assessment body the same questions arrive from the ministry or the programme.

What is a managed entry agreement, and have you worked on one?

It is coverage granted with conditions attached: a price arrangement, a population limit, a review point, or an agreement to collect data and revisit the decision. In the Gulf the same idea appears as a government agreement to cover treatment costs for a defined group of eligible patients, which is what the cystic fibrosis programme produced, and as national approval with a treatment programme attached in the porphyria work. I worked the medical side of those arrangements. I have not negotiated a European style agreement.

How do real-world data and real-world evidence relate to coverage decisions?

Data is what is collected; evidence is what it supports once the question and the method are clear. In rare disease, coverage often turns on what a controlled trial cannot supply: how many patients are really diagnosed, how they present, and what treatment looks like inside a specific health system. I have worked on Gulf real-world evidence in sickle cell disease, set up a post-launch registry for an ultra rare therapy, and used local data as part of the access case rather than as an appendix to it.

How do you handle orphan drug pricing?

Pricing is not my function and I do not negotiate it. What medical affairs owes that conversation is accuracy: a defensible patient number, a clear picture of what the therapy changes for those patients, and an honest account of the uncertainty that remains. Orphan drug pricing arguments fail when the clinical case is inflated to match the number, and the person who has to answer for that in front of a committee is usually the medical lead.

Do you work with distributors and agencies on access, or only with manufacturers?

Both, and much of my record is the distributor side. I have been the medical counterpart to regional distribution partners, representing eighteen companies across the Gulf. That means building an access case with incomplete local data, inside a health system I do not own, alongside a commercial team with its own pressures. It is the environment I know best, and it is where most of my access work happened.

How do we start?

Send me a message with the therapy area, the market and where you are in the process: pre-launch, a dossier to prepare, a coverage conversation that has stalled, or a diagnosis pathway that has to be built first. If it is something I do, I will tell you what it would involve. If it is not, I will tell you that too. I answer from my own address, and your details stay with me.

Tell me about the market and the decision point

A therapy area, a market and a timeline is enough to start. If the question is a dossier, a coverage conversation or a patient pathway that has not been built yet, tell me which, and I will tell you how I would approach it. I answer from my own address, usually within a day.

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