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If you live in the Commonwealth of Virginia and are looking for low cost health insurance, you and/or y

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

our children may be eligible for coverage under one or more of the three FAMIS health plans sponsored b

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

y the Commonwealth.

The three FAMIS (Families Access to Medical Insurance Security) plans are as foll

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ws:

FAMIS – The Children's Health Insurance Program: This program for children covers services

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

such as:

doctor visits
Well-baby checkups
Hospital visits
Vaccinations
Prescrip

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ion medicine
Tests and x rays
Dental care
Emergency care
Vision care
Mental h

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ealth care

FAMIS – Moms: This program provides health care for pregnant women up to two m

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nths after the pregnancy.

Smiles for Children: This program provides diagnostic, preventive,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

restorative/surgical procedures and orthodontics (Basically the same coverage as provided through Medic

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

id) Since this program is primarily for children, it provides limited necessary diagnostic/oral surgery

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

services for adults (emergency only)

The beauty of this program is that the co-payments are only $2.0

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

0 or $5.00. Regular check-ups are free and there are no monthly premiums or enrollment costs. With S

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

iles for Children, there are no co-payments or cost for dental services. However, you must use dental

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

providers that are within the network.

To qualify for any of the FAMIS programs the applicant must be

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

US citizen under 19 (for the Children's program), live in Virginia and not covered by another plan. Y

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ou must not have had insurance for 4 months and are not eligible for Medicaid. There are also income r

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

quirements. For example, the gross income for a family of 4 must not exceed $40,000 annually. The FA

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

MIS website (www.famis.org ) has a family income calculator in which potential insureds may check their

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

income to see if they qualify.

The Commonwealth of Virginia realizes that quality medical care is impo

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

rtant, and has successfully provided a low cost health insurance program for their low income residents

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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