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Discussing with labs and KOLs it appear clear now that the future of NASH treatment will rely on combinaisons of drugs. 

It is to early to talk of packaged combos, because they will need more clinical trials to evaluate the doses ratios valuable for the majority of patients and it will take time.

What we are talking about is combinaisons of prescriptions.

The most admitted scheme of future NASH  treatment is the combinaison of a backbone treatment targeting the metabolic causes of NASH and, if possible, the commorbidities of the disease ( T2D, hyperlipidemia, etc …), and a complementary treatment targeting fibrosis at start.

Patients with mild fibrosis (F1 and maybe F2) could be treated with the backbone treatment only, most advanced fibrosis like F3 and F4 ( compensated cirrhosis) could be completed with a drug targeting specifically hepatic fibrosis. 

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As more as the 'backbone treatment' will reduce inflammation and stop the fibrogenesis, the complementing treatment would be reduced, after a certain time ( maybe 1 or 2 years), only the 'backbone treatment' will be maintained, maybe for the rest of the life of patients.

The average age of NASH patients is close to 55 years, it means that the 'backbone treatment' could be prescribed for an average duration of 20 years., a contrario, anti-fibrotic complementary treatments could be prescribed for an average duration of 2 years.

It means, that a 'backbone treatment' should present a perfect safety, and more than that,  no adverse effects reducing the patient compliance to the treatment, when dedicated antifibrotic treatment can support some small adverse effects. 

Economy of health principles show that treatments supposed to be prescribed  as backbone treatment and for lifetime need to have a low cost. At the opposite, short duration treatments can be more expensive. 

Those points explain the quarrels supported by labs on the NASH treatments strategy. (you can read an article related here).

The market forecast engine was completely rewrited to include those principles :

At start, each drug was tagged regarding the following criterias allowing to obtain the potential, 'backbone treatment' label  :

  • Targeting metabolic causes of NASH (not targeting advanced fibrosis only )
  • A perfect safety as known to date.
  • No aggravation of comorbidities as CV risk or T2D
  • No adverse effects which could reduce the patients compliance to the treatment.
  • If possible, positive action on glycemy and lipidemia.

The other drugs are classed as complementary treatment, mainly targeting fibrosis.

The market forecast is now computed in two times :

A first competition including only 'backbone treatments ' of disease :

This competition give a big advantage for the firsts drugs on the market.  

It is known that backbone treatments are rarely modified by prescriptors if the patients compliance to the treatment is good. So, as installed, those drugs benefit from a good market shield against new comers. 

Market shares are computed on a large panel of patients from F1 to F4. 

Average prices are not estimated very high ( from 10000 $ / year to 1000 $/ year depending of countries)

A second competition including all the other drugs :

Regarding the short period of treatment, the all market would be supposed to decrease as the backbone treatments are expanding, but because of the very low diagnosis rate of the disease, we supposed that the new diagnosed patients will compensate 'end of complementary treatment' rates.

Market shares are computed on a reduced panel of patients from F2 to F4 depending of the drug profile. 

Average prices are estimated higher ( from 15000 $ / year to 4000 $/ year depending of countries)

All the computation are done separately for each country.

The principle of computation is as follows:

We divided the NASH patients into 20 groups:

2 large groups: CV risk / or not, subdivided into 2 subgroups: diabetics (T2) or not, each of these 4 subgroups being distributed according to their grade of Fibrosis (0 to 5)

To help, each group is named as follows: F (grade of fibrosis) (N) C (N) D

Example: for patients with diabetes without cardiovascular risk and a fibrosis grade of 2, the group is named F2NCD.

Some drug target only certain grade of fibrosis, others are poorly indicated for patients with cardiovascular risk , etc 

All drug recieve an individual note (0 to 1) for each group of patients regarding the publications.

For each of these groups a curve is calculated month by month to simulate the maturation of the market, its purpose is to model the progression of the knowledge of the disease and the evolution of the diagnosis rate over time.

It is different for each group because it is obvious that a diabetic patient with advanced fibrosis is more likely to be diagnosed quickly than a patient with a fibrosis grade of 1, non-diabetic and without identified CV risk.

A second progressive factor is calculated month by month for all the patients, it is the progression of the rate of care related to the management of the disease, it starts from 0 and progresses linearly to reach its maximum rate  in 15 years . The maximum rate of care is different for each country, it varies between 1% for a country like Sudan and 80% for Germany or France, or 70% for the USA. 

It is mainly representative of the country healthcare system and insurance covering.

NAFLD total adult patients population is calculated for each country on the basis of known and published ratios.

Based on NAFLD population, a global NASH population is estimated on the basis of the (published) average ratio of 24% of NAFLD patients. 

This NASH population is then subdivided into subgroups using published ratios of diabetic rates, CV risks and each grade of fibrosis.

By multiplying the number of patients thus calculated by the first curve, group by group and then with the second curve, this time globally, one obtains, group by group and month by month the number of theoretical patients. diagnosed and potentially treated. A population growth curve unique for each country is applied to the final month by month.

Those patients will be distributed among drugs regarding their future estimated market share.

Exemple : Forecast of NASH patients treated in USA

NEW !  some remarks were done on the previous way to compute market shares because it was not integrating the treatment compliance by the patients.

The method was entirely revised as follow :

We now suppose that only a little part of patients under prescription change their drug each year. the rate is different from one drug to the other because of the adverse effects. 

We now give a compliance note to each drug as a percentage of prescriptions reiterated from year to year ( exemple 90% mean that the drug lost 10% of patients under prescription each year). This rating is in process.

For each drug ,  we now reconduct each month the number of patients under treatment the previous month but we remove a part of it depending of this rate. Those ‘new free' patients are added to the new patients of  the month as computed precedently and all those new patients are redispatched to the drugs, segment by segment.

At the end we obtain for each country, each medicine each group and each month the number of patient who will be treated.

This is a big amount of figures to compute, 200 countries x 50 drugs x 120 months x 20 groups = 24 million figures, (for those who think I calculate it with a wet finger).

Once the number of patients calculated per group, it is summoned to obtain the total of treated patient of all groups, per month, by country, and by drug.

For each country a realistic selling price is determined for each drug (from 1000$/year to 15000$/year)

Maps of prices used in the forecast are available HERE

However it would be too simple to have a fixed price, so we evaluate month by month  the number of drugs present on the market of each country. 

When more than 4 drugs are present on the same segment, a discount rate is progressively applied to all drug prices in the country (to date, discount is arbitrary limited to 35%).

Then,month by month price of each drug is multiplied with the previously calculated patient number of each drug  which gives a forecast income month by month which is then presented by quarter or by year according to diagrams !

The forecast can be updated several time per weeks depending of news flow or results, so dont be surprised if the values are modified from time to time.

To date, the list of countries included in the forecast is the following

The drugs included in the forecast are the following

The forecast income of drugs charts are below :

ANNEXES (follow the links)

Interactive drugs incomes by country.

ZOOM ON USA FROM 2024 to 2028

A snapshot is proposed in 2025 in terms of  NASH patients treated.


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